Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
*Domestic* - FL, NY, PA, *International*- China
Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.
PREMIUM PROTEIN III For kids Nutritional Supplement, NET WT 16 OZ (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219.  Made in USA
Premium Protein III, NET WT 16 OZ. (454g) www.greenwoodbiotech.com
Super Natural Children's Growth Formula Dietary Supplement, 90 Tablets, Manufactured for GW Biotech Greenwood Biotech, LLC New York.  Made in USA.
DIETARY SUPPLEMENT BLUE ROCK HOLISTICS SUPER SHIELD, 90 Vegetable Capsules, Distributed by: Holistic Blends, Inc. 925 State Fair Blvd Syracuse, NY 13209 USA.
RISHI MUSHROOM SPORE, 60 count. 24 PER BOX
Joint Lubrica Rebuilds, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305.  Made in USA.
Premium Protein III Nutritional Supplement, NET WT 16 OZ. (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219.  Made in USA
Byron J. Richards Wellness resources Hyaluronic Acid Dietary Supplement, 60 Capsules, Distributed by Wellness Resources, Inc. 7155 Amundson Avenue, Minneapolis, MN 55439 800-717-WELL.
Joint Optima Rebuilds, Lubricates and Soothes Joints, Triple Strength, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305.  Made in USA.
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Mammoplasty Pack, Kit number AMS2535    convenience custom kits used for general surgery in hospital operating room
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A.    convenience custom kits used for general surgery in hospital operating room
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A.  convenience custom kits used for general surgery in hospital operating room
Morris Lap Pack, Kit number PSS3199 and PSS3199(A    convenience custom kits used for general surgery in hospital operating room
General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B.  convenience custom kits used for general surgery in hospital operating room
Major Pack, Kit Number	PSS3516 and PSS3516(A    convenience custom kits used for general surgery in hospital operating room
Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A  convenience custom kits used for general surgery in hospital operating room
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A.  convenience custom kits used for general surgery in hospital operating room
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422  convenience custom kits used for general surgery in hospital operating room
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D  convenience custom kits used for general surgery in hospital operating room
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A.  convenience custom kits used for general surgery in hospital operating room
Liposuction Pack, Kit number AMS3323    convenience custom kits used for general surgery in hospital operating room
Basin Pack, kit number AMS2497	  convenience custom kits used for general surgery in hospital operating room
Basic Extended Pack, kit part number AMS4421.    convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:    79640 1/10/2018
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C.  convenience custom kits used for general surgery in hospital operating room
Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2    convenience custom kits used for general surgery in hospital operating room
Nasal Pack, Kit number PSS2186    convenience custom kits used for general surgery in hospital operating room
Peri GYN, Kit number PSS2193(A    convenience custom kits used for general surgery in hospital operating room
Endoscopy Pack, Kit number PSS1646    convenience custom kits used for general surgery in hospital operating room
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449  convenience custom kits used for general surgery in hospital operating room
C-Tray Pack, Kit number PSS2707and PSS2707(A  convenience custom kits used for general surgery in hospital operating room
General Pack I, Kit number CMP1811(B  convenience custom kits used for general surgery in hospital operating room
Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B  convenience custom kits used for general surgery in hospital operating room
General Plastics Pack, Kit number 008617-1  convenience custom kits used for general surgery in hospital operating room
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A  PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706    convenience custom kits used for general surgery in hospital operating room
General Surgery Pack, Kit number PSS1380(A  convenience custom kits used for general surgery in hospital operating room
Newport Coast Basic Pack, Kit number 007484-1    convenience custom kits used for general surgery in hospital operating room
Laparotomy Tray, Kit number PSS1538    convenience custom kits used for general surgery in hospital operating room
Lot numbers/Expiration dates:    57508 6/19/2016
Total Hip Pack, Kit number PSS2956    convenience custom kits used for general surgery in hospital operating room
Lithotomy Pack, Kit number AMS2333 and AMS2333(A    convenience custom kits used for general surgery in hospital operating room
Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669.  convenience custom kits used for general surgery in hospital operating room
GYN Pack, Kit number PSS2643  convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:    58662 4/6/2015
Facial Tray, Kit number PSS1558(A    convenience custom kits used for general surgery in hospital operating room
Virginia Custom Pack, Kit number RMS1744    convenience custom kits used for general surgery in hospital operating room
Universal Pack, Kit number AMS2036    convenience custom kits used for general surgery in hospital operating room
Abdominoplasty Pack, Kit number AMS3326  convenience custom kits used for general surgery in hospital operating room
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B  convenience custom kits used for general surgery in hospital operating room
Basic Kit, Part numbers BP1110(C and CMP1109(A.  convenience custom kits used for general surgery in hospital operating room
Dr. Fetters Hand Pack, Kit number AMS3690    convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:    75188 12/2/2015
Ortho Pack, Kit number PSS3466 and PSS3466(A    convenience custom kits used for general surgery in hospital operating room
ENT Tray, Kit number AMS1195(A    convenience custom kits used for general surgery in hospital operating room
Knee Pack, Kit number AMS4211  convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:    77332 8/10/2017
Pacemaker Kit, Kit number AMS4281    convenience custom kits used for general surgery in hospital operating room
Student Pack-NS, Kit number PSS2788    convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:    58594 7/23/2016
Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A  convenience custom kits used for general surgery in hospital operating room
Bleph Pack, Kit part number AMS3325  convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:  71657 3/14/2016
Laparoscopy Pack, Kit number AMS2537 and AMS2537(A    convenience custom kits used for general surgery in hospital operating room
Eye Tray, Kit number PSS1834 and PSS1939    convenience custom kits used for general surgery in hospital operating room
Local Pack, Kit number AMS1544    convenience custom kits used for general surgery in hospital operating room
Augmentation Mammoplasty Tray, Kit part number AMS2234.  convenience custom kits used for general surgery in hospital operating room
Upper Torso Tray, Kit number PSS1554(B    convenience custom kits used for general surgery in hospital operating room
Minor Ortho Pack, Kit number 002646-12 and 002646-13    convenience custom kits used for general surgery in hospital operating room
Spine Pack, Kit number AMS3753 and AMS3783(A    convenience custom kits used for general surgery in hospital operating room
Knee Scope Pack, Kit number AMS2498 and AMS2498(A  convenience custom kits used for general surgery in hospital operating room
Ortho Minor Pack, Kit number AMS3710    convenience custom kits used for general surgery in hospital operating room
D&C/GYN/Hysteroscopy Pack, Kit number PSS3341  convenience custom kits used for general surgery in hospital operating room
OB/GYN Pack, Kit number AMS2038    convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:  58648 4/17/2015
Dr. Casey Pack, kit number AMS4313  convenience custom kits used for general surgery in hospital operating room
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070.    convenience custom kits used for general surgery in hospital operating room
Plastic Kit, Kit number CMP1084(B    convenience custom kits used for general surgery in hospital operating room
Minor Lap Pack, Kit number AMS2624    convenience custom kits used for general surgery in hospital operating room
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A    convenience custom kits used for general surgery in hospital operating room
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A.    convenience custom kits used for general surgery in hospital operating room
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430.  convenience custom kits used for general surgery in hospital operating room
Transvaginal Pack, Kit number CMP1767    convenience custom kits used for general surgery in hospital operating room
Minor Tray	AMS2685  convenience custom kits used for general surgery in hospital operating room
Minor Pack	AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A.  convenience custom kits used for general surgery in hospital operating room
Surgical Pack, Kit number PSS3540 and PSS3540(A    convenience custom kits used for general surgery in hospital operating room
Mok Eye Pack, Kit number PSS2640      convenience custom kits used for general surgery in hospital operating room
Vaginal Pack, Kit number AMS1722    convenience custom kits used for general surgery in hospital operating room
Lot Numbers/ Expiration Dates:    62061 6/14/2014
Pelviscopy/Laparoscopy Pack, Kit number PSS3342    convenience custom kits used for general surgery in hospital operating room
Open Procedure Pack II, Kit number RMS1740(A    convenience custom kits used for general surgery in hospital operating room
GLBSC Minor Pack, Kit number PSS2644  convenience custom kits used for general surgery in hospital operating room
General Pack II, Kit number CMP1812(B  convenience custom kits used for general surgery in hospital operating room
Bayview Abdominoplasty Pack, Kit part number 009079-1  convenience custom kits used for general surgery in hospital operating room
Plastic Pack	, Kit number AMS1833(A    convenience custom kits used for general surgery in hospital operating room
Podiatry Kit	PSS1040(A, PSS1040(B, and PSS1040(C    convenience custom kits used for general surgery in hospital operating room
Major Laparotomy Pack - NS, kit number AMS4347  convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:    78422 11/9/2015
Hand Tray	PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D  PSS2365(E,   convenience custom kits used for general surgery in hospital operating room
Body Contour Pack, Kit part number PSS1749    convenience custom kits used for general surgery in hospital operating room
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B.  convenience custom kits used for general surgery in hospital operating room
Custom Tray, Kit numbers: PSS1836 and PSS1836(A  convenience custom kits used for general surgery in hospital operating room
Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327  convenience custom kits used for general surgery in hospital operating room
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A.   convenience custom kits used for general surgery in hospital operating room
Port Access Kit, Kit number PSS1505(C  convenience custom kits used for general surgery in hospital operating room
Lot Numbers/ Expiration Dates:    63411 7/26/2015
Extremity Pack-N Brunswick, kit number PSS1866(A    convenience custom kits used for general surgery in hospital operating room
Hystero Pack, Kit number PSS3535  convenience custom kits used for general surgery in hospital operating room
Lot Numbers/ Expiration Dates:    74708 4/23/2017
Head Pack, Item number PSS1934(B  convenience custom kits used for general surgery in hospital operating room
Hernia Pack, Kit number AMS1519  convenience custom kits used for general surgery in hospital operating room
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B    convenience custom kits used for general surgery in hospital operating room
Face Pack, Kit number AMS3641    convenience custom kits used for general surgery in hospital operating room
Dr. Harrimans Kit, Kit number PSS3600  convenience custom kits used for general surgery in hospital operating room
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A,   convenience custom kits used for general surgery in hospital operating room
Robotic Pack, Kit number AMS4389    convenience custom kits used for general surgery in hospital operating room
Taymour GYN Pack, Kit number  PSS2642    convenience custom kits used for general surgery in hospital operating room
Custom Pack - with Introducer Kit,  Kit number TVS4011NI(K and TVS4011NI(L  convenience custom kits used for general surgery in hospital operating room
Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C  convenience custom kits used for general surgery in hospital operating room
Cath Pack, kit number AMS4283    convenience custom kits used for general surgery in hospital operating room
Lap Band Pack, Kit number AMS1785(A    convenience custom kits used for general surgery in hospital operating room
Major Breast Pack, Kit number AMS3409  convenience custom kits used for general surgery in hospital operating room
Hall SAP, Kit number SRK1031(A  convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:    57039 5/21/2016
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A   convenience custom kits used for general surgery in hospital operating room
Knee Arthroscopy Pack	AMS2610, AMS2610(A, AMS3236,  PSS2188(A, and PSS2208(A  convenience custom kits used for general surgery in hospital operating room
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073.  convenience custom kits used for general surgery in hospital operating room
Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A    convenience custom kits used for general surgery in hospital operating room
GYN Lap Pack, Kit number PSS2194(B  convenience custom kits used for general surgery in hospital operating room
Dr. Fritsch Pack, Kit number AMS2696    convenience custom kits used for general surgery in hospital operating room
Foot Pack, Kit number AMS3637  convenience custom kits used for general surgery in hospital operating room
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A    convenience custom kits used for general surgery in hospital operating room
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C  convenience custom kits used for general surgery in hospital operating room
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689  PSS1689(A  convenience custom kits used for general surgery in hospital operating room
Peri Kit, Kit number PSS1037    convenience custom kits used for general surgery in hospital operating room
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15  convenience custom kits used for general surgery in hospital operating room
Vein Kit - No Introducer	TVS4027-NI(A    convenience custom kits used for general surgery in hospital operating room
Set Up Pack, Kit number PSS3574(A    convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:    80547 8/8/2017
DND Pack, Kit number AMS3846  convenience custom kits used for general surgery in hospital operating room
Lipo Pack, Kit number AMS4420    convenience custom kits used for general surgery in hospital operating room
Lot number/Expiration date:    79639 1/9/2018
Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758,  AMS2758(A, AMS2972,  AMS4264,  AMS4309,  PSS1833, and PSS1848(A.     convenience custom kits used for general surgery in hospital operating room
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D  convenience custom kits used for general surgery in hospital operating room
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D.    convenience custom kits used for general surgery in hospital operating room
Plastic General Pack, Kit number AMS4215    convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:  77336 7/20/2017
Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B    convenience custom kits used for general surgery in hospital operating room
GYN-Laparoscopy Tray	AMS1196(A  convenience custom kits used for general surgery in hospital operating room
Eye Plastic Tray, Kit number PSS1931(A    convenience custom kits used for general surgery in hospital operating room
C-Birth Pack, Kit part number AMS2037 and AMS2037(A  convenience custom kits used for general surgery in hospital operating room
Set-Up Pack, Kit number PSS1305(B and PSS1305(C    convenience custom kits used for general surgery in hospital operating room
Laparoscopic Pack, Kit number AMS2499    convenience custom kits used for general surgery in hospital operating room
Total Joint Pack, Kit number 006358-5 and 006358-6    convenience custom kits used for general surgery in hospital operating room
Minor Lithotomy Pack, Kit number 002650-7    convenience custom kits used for general surgery in hospital operating room
Cardiac Cath Pack, kit number AMS2707  convenience custom kits used for general surgery in hospital operating room
Major Ortho Pack, kit number 002647-12 and 002647-13    convenience custom kits used for general surgery in hospital operating room
Total Knee Pack, Kit number AMS4010(A    convenience custom kits used for general surgery in hospital operating room
Lot Number/ Expiration Date:    78940 9/5/2017
Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8  convenience custom kits used for general surgery in hospital operating room
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214.    convenience custom kits used for general surgery in hospital operating room
General Male Pack, Kit number AMS1580  convenience custom kits used for general surgery in hospital operating room
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A    convenience custom kits used for general surgery in hospital operating room
D & C Kit, Kit number CMP1466 and CMP1466(A  convenience custom kits used for general surgery in hospital operating room
Dr Mullins Kit, kit number PSS1861(A    convenience custom kits used for general surgery in hospital operating room
Custom Venous Kit, TVS4024(C    convenience custom kits used for general surgery in hospital operating room
Lumbar Laminectomy Pack, Kit number AMS2501    convenience custom kits used for general surgery in hospital operating room
Custom Arterial Pack, kit number RMS1712(F    convenience custom kits used for general surgery in hospital operating room
Lot Number/Expiration Date:    59045 8/18/2016
Basic Setup Pack, kit part number AMS1787(A	  convenience custom kits used for general surgery in hospital operating room
Major General Pack, Kit number 002645-11 and 002645-12    convenience custom kits used for general surgery in hospital operating room
Major Lithotomy Pack, kit number 002641-5 and 002641-6    convenience custom kits used for general surgery in hospital operating room
Lap Gallbladder Pack, Kit number AMS3707    convenience custom kits used for general surgery in hospital operating room
Major Kit, Kit number PHC1307(A  convenience custom kits used for general surgery in hospital operating room
Extremity Tray, Kit number AMS1200(B and AMS1200(C    convenience custom kits used for general surgery in hospital operating room
Ortho Kit, Kit number PSS1039(A and PSS1039(B    convenience custom kits used for general surgery in hospital operating room
HSG Pack, Kit number PSS3287  convenience custom kits used for general surgery in hospital operating room
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B  convenience custom kits used for general surgery in hospital operating room
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.
HeartWare Ventricular Assist System Controller     Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Loose connector ports in controller body.
All Heartware Controllers manufactured after September 2014.  US Model No: 1400, 1401XX, 1403US.   International Model No: 1400, 1401XX, 1407XX.
Product was directly distributed to restaurant, retail, and wholesale customers in GA. IL, KS, and MO.  The GA firm sent product to a public storage facility in TX.  There was no foreign, military, or government distribution.
Shell eggs, various sizes, packaged in the following ways:  6-count cartons, 10-count cartons, 12-count cartons, 18-count cartons, 15 dozen cases, and 30 dozen cases; under the brand name Good Earth Egg Company and MO license # D-01124.  The responsible firm name is Good Earth Egg Company, Bonne Terre, MO
all date codes up to and including 006 -- Sell by 02/05/2016
U.S. distribution to the following; CA, OR, UT, HI, TX, AZ, NV, NY, OH, VA, SD, NJ, FL, WA, ID, GA, MD, AK, CO, IL, MN, NM, TX, OK, MO, LA, DC, IN, NE, NC, WI, SC, CT, TN    No foreign distribution.
Awareness  Boost Tea  Dietary Supplement  Passion Fruit    Net Wt 7.4 oz.    Distributed by & for all inquiries: Awareness Corporation  P.O. Box 2289 Chandler, AZ 85244
Boost Tea is being recalled for potential Salmonella contamination.
Deluxe Fruit Tray 52 oz. UPC 427979661 packaged in clear plastic round container
Product has the potential to be contaminated with Listeria monocytogenes.
HEB Ready Fresh Go Carrots, Apples with Yogurt Pretzels and Ranch Dip 4.75 oz. UPC 4122002119 packaged in clear plastic tray
Apples & Grapes 10 oz. UPC 4122087666 packaged in clear plastic container
HEB Ready Fresh Go Sliced Red Apples With Caramel Dip 16 oz UPC 4122079830 packaged in clear plastic bag
HEB Ready Fresh Go Pineappple, Grapes & Apples with Banana Chips 6 oz. UPC 4122002138 packaged in clear plastic tray
HEB Ready Fresh Go Fresh Fruit Medley 7 oz. UPC 4122002402 packaged in clear plastic tray
HEB Ready Fresh Go Sliced Red Apples 22.5 oz UPC 4122018603 packaged in clear plastic bag and Value Pack Sliced Apples 28 oz. UPC 4279796149 packaged in clear non-flexible plastic bowl and Large Sliced Red Apples 17 oz. UPC 4122087646 packaged in a clear non-flexible plastic container.
HEB Ready Fresh Go Carrots, Apples & Celery with Ranch Dip 6.75 oz. UPC 4122054448 packaged in clear plastic tray
Fruit Party Tray 45 oz. UPC 4122087997 packaged in clear plastic rectangle container
Fruit & Veg Combo Tray 40 oz. UPC 4279796688 packaged in clear plastic rectangle tray
HEB Ready Fresh Go Carrots, Apples with Sesame Sticks & Hummus 6 oz. UPC 4122002144 packaged in clear plastic tray
Red & Green Apples Large 17 oz. UPC 4122087649 packaged in clear plastic container
Adwe Naturals Prenatal Vitamin Manufactured for: Adwe Laboratories 1274 49 Street Brooklyn, NY 11219   UPC 040168805079
Adwe Prenatal tablets are being recalled due to a concern of potency of folic acid.
Products were only distributed to one retail store located in Grande, OR
2 bagels per package - plastic bag with twist tie.
Undeclared wheat and milk (cheese ingredient)
This information was hand written on a business card, no separate ingredient statement.
Undeclared wheat, milk, and soy (Lecithin)
Undeclared wheat and milk (butter ingredient)
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Ninja-X, 4200 mg, 1 capsule per pack,  24 single packs per box.
Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Birdy 3 in 1 Robusta Coffea Mix, 445.5 g in a red sealed plastic bag, Product of Thailand, UPC 8850250007425
Birdy 3 in 1 Coffee Mix (Robusta) may contain undeclared milk allergen and the nutritional labeling is unclear.
Product was shipped to the following states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI AND WY and the District of Columbia.     Product was also shipped to Canada.
5,336 cs/6/12.7 oz canisters + 5/12.7 oz canisters
The firm received complaints that the wrong size scoop was in the product canister.  Use of this scoop would only yield 60% nutrition instead of 100% nutrition.
Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV.    Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Model: OER-Pro, All serial numbers affected
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
US Distribution to the states of :  OH, OR, WA  and Internationally to the country of Italy.
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060    A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed.  The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components.  All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.
FE Jalapeno 709, Product Code 22709.  50 lb corrugated case with polyliner.  Manufactured by:  Quali Tech, 318 Hazel tine Drive, Chasma, MN  55318 USA
Quali Tech has been notified by a supplier that they received material with the potential presence of E. coli O 121 bacteria.
FE Jalapeno 321A, Product Code 22321A.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.
FI Dry Blueberry / Strawberry Blend, Product Code 21585.  40 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Spinach 352, Product Code 22352.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Bacon, Product Code 22763.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Bacon, Product Code 24117.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Green Bell Pepper, Product Code 22733.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE RedBell Pepper 339, Product Code 22339.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Red Bell Pepper, Product Code 22708.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
PE Blueberry, Product Code 27136.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Bacon 286, Product Code 22286.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Rainbow Blend 714, Product Code 22714.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE RedBell Pepper, Product Code 22760.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Green Bell Pepper 338, Product Code 22338.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Carrot 281, Product Code 22281.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Maple, Product Code 27128.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Rainbow Blend, Product Code 22795.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
FE Cheddar Cheese, Product Code 22518.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA
AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.
COCONUT LOBSTER TAIL, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Product was manufactured with flour recalled due to E. coli O121 contamination.
Item number: K8073, Lot/Julian Code: PM15M18 / 15352.
APPLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K7165, Lot/Julian Code: PM15M14 / 15348.
PANANG SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K3634, Lot/Julian Code: PM15M22 / 15356.
LOBSTER POT PIE, 180 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K7059, Lot/Julian Code: PM16A15 / 16015.
MINI VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
152 cases/114 cases (200 units per case)
Item number: K8661, Lot/Julian Code: PM15M18 / 15352 and PM15M17 / 15351.
COCONUT SHRIMP, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
205 cases/162 cases (100 units per case).
Item number: K800, Lot/Julian Code: PM16A12 / 16012 and PM15M18 / 15352.
MAC & CHEESE POPPERS, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K418, Lot/Julian Code: PM15M09 / 15343
MINI VEGETABLE EGGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K8662, Lot/Julian Code: PM15M10 / 15344.
VEGETABLE SAMOSA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K7195, Lot/Julian Code: PM15M16 / 15350.
MINI MUSHROOM QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
119 cases/50 cases (200 units per case).
Item number: K468, Lot/Julian Code: PM15M16 / 15350.
MOZZARELLA CALZONE, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K8871, Lot/Julian Code: PM15M08 / 15342.
CRAB CAKES, 1.25 OZ, 112 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K8036, Lot/Julian Code: PM15M16 / 15350.
COZY SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K363, Lot/Julian Code: PM15M18 / 15352.
SWEET POTATO PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K7210, Lot/Julian Code: PM16A18 / 16018
MINI DEEP DISH MUSHROOM PIZZA, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
176 cases/115 cases (200 units per case).
Item number: K7954, Lot/Julian Code: PM15M18 / 15352 and PM15M17 / 15351.
MINI CLASSIC FRENCH QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K462, Lot/Julian Code: PM15M10 / 15344.
MINI FLORENTINE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K460, Lot/Julian Code: PM16A15 / 16015.
SHRIMP SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K867, Lot/Julian Code: PM15M10 / 15344.
WILD MUSHROOM IN PHYLLO, 100 CT and 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K751, Lot/Julian Code: PM16A13 / 16013 and Item number: K7515, Lot/Julian Code: PM15M16 / 15350..
ROASTED VEGETABLE, 200 CT, TART Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K7051, Lot/Julian Code: PM15M03 / 15337 and PM15M04 / 15338.
FOUR CHEESE PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260
Item number: K7234, Lot/Julian Code: PM16A13 / 16013.
CRAB CAKES, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K802, Lot/Julian Code: PM15M03 / 15337.
SHRIMP EMPANADA Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K718, Lot/Julian Code: PM15M18 / 15352.
MUSHROOM TART, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K707, Lot/Julian Code: PM15M18 / 15352..
MINI CHEESE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K467, Lot/Julian Code: PM15M16 / 15350.
VEGETABLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Item number: K716, Lot/Julian Code: PM15M22 / 15356
VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
197 cases/152 cases/225 cases/66 cases/26 cases (200 units per case)
Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM  The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM.  The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
CA - Bay area and to one firm warehouse in HI but product was not further distributed.
Artichoke Heart with Boursin Mousse Breaded             Pack Size: 200 ea. per case         UPC: 11784-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.
Shrimp 21/25 Coconut Butterfly             Pack Size: 200 ea. per case         UPC: 23502-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Stretched Coconut Shrimp             Pack Size: 180 ea. per case  UPC: 22102-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Artichoke Bottom Ratatouille             Pack Size: 240 ea. per case         UPC: 18010-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Shrimp Coconut Brochette             Pack Size: 156 ea. per case  UPC: 23811-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Breaded Cheese Ravioli             Pack Size: 1 oz. ea. 15 lb. per case  UPC: 18890-03        Keep Frozen:  Gourmet Foods, Hayward, CA
Artichoke Heart Breaded with Goat and Cheddar Cheese :             Pack Size: 240 ea. per case;  UPC: 13014-03       Keep Frozen:  Gourmet Foods, Hayward, CA
Strudel Wild Mushroom             Pack Size: 240 ea. per case    UPC: 17338-03  Keep Frozen:  Gourmet Foods, Hayward, CA
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product.
Beginning Lot Code 110609X to Ending Lot Code 20160308X
Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Lot number M543990 (1 each or box of 6 each), exp 10/2018  Lot number M545780 (1 each or box of 6 each), exp 10/2018  Lot number M569020 (1 each or box of 6 each), exp 01/2019  Lot number M578140 (1 each or box of 6 each), exp 02/2019
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Lot number M548370 (1 each or box of 6 each), exp 11/2018  Lot number M578150 (1 each or box of 6 each), exp 02/2019
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Lot number M545040 (1 each or box of 6 each), exp 10/2018  Lot number M586070 (1 each or box of 6 each), exp 03/2019
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Lot number M546500 (1 each or box of 6 each), exp 10/2018
Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD ---   For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders
US: 60,372 sales units; Foreign: 145,611 sales units
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit),  Unique Device Identifier No. 10758750000340, Rx ONLY, IVD ---   For in vitro diagnostic use only.
US: 18,749 sales units; Foreign: 94,928 sales units
VITROS Chemistry Products GLU Slides, REF/Product Code  170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD ---    For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
US: 192,459 sales units; Foreign: 231,710 sales units
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.  Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.
Current/In-date GENs 10, 11, 20 through 31
VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD ---    For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
US: 32,081 sales units; Foreign: 29,932 sales units
Domestic: Nationwide, Washington D.C., and Puerto Rico. Foreign: UAE, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Comfort Bath Cleansing Washcloths    c) DEODORANT BATH 5-PACK, 84 packages per case, Product Code 7815    d) DEODORANT BATH 8-PACK, 60 packages per case, Product Code 7818    i) DEODORANT BATH 8-PACK, 44 packages per case, Product Code 7942    j) DEODORANT CLEAN-UP BATH 3-PACK, 100 packages per case, Product Code 7943
Potential contamination with the bacteria, Burkholderia cepacia.
c) DEODORANT BATH 5-PACK, Product Code 7815    d) DEODORANT BATH 8-PACK, Product Code 7818    i) DEODORANT BATH 8-PACK, Product Code 7942    j) DEODORANT CLEAN-UP BATH 3-PACK, Product Code 7943    No expiration dates.
Incontinence Clean-Up Cloths with dimethicone and aloe, Fragrance-Free, Product Code 7505, 8 cloths per package, 30 packages per case
M-Care Meatal Cleansing Cloths for the Foley Catheterized Patient    a) M-CARE CLEANSING CLOTH 2-PACK, 168 packages per case, Product Code 7952    b) M-CARE CLEANSING CLOTH 4 2-PACKS, 36 packages per case, Product Code 7954
Comfort Bath Cleansing Washcloths    a) ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7803    b) Dignity Health ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7805    c) COMFORT ESSENTIAL BATH 5-PACK, 84 packages per case, Product Code 7855    d) ESSENTIAL BATH 5-PACK, Fragrance Free, 84 packages per case, Product Code 7856    e) COMFORT BATH 8-PACK, Fragrance Free, 44 packages per case, Product Code 7903    f) COMFORT BABY BATH 4-PACK, Fragrance Free, 110 packages per case, Product Code 7907    g) COMFORT BATH 5-PACK, Fragrance Free, 48 packages per case, Product Code 7956    h) BATH CLOTHS 5-PACK, Fragrance Free, 78 packages per case, Product Code 7959    i) BATH CLOTHS 8-PACK, 88 packages per case, Product Code 7982    j) IMPREVA BATH 5-PACK, Fragrance Free, 78 packages per case, Product Code 7987    k) IMPREVA BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7988    l) COMFORT BATH 2-PACK, Fragrance Free, 96 packages per case, Product Code 9775    m) ESSENTIAL BATH 8-PACK, 60 packages per case, Product Code 7800-MC    n) COMFORT BATH 2-PACK, 96 packages per case, Product Code 9702-P
a) ESSENTIAL BATH 8-PACK, Product Code 7803    b) ESSENTIAL BATH 8-PACK, Product Code 7805    c) COMFORT BATH 5-PACK, Product Code 7855    d) ESSENTIAL BATH 5-PACK, Product Code 7856    e) COMFORT BATH 8-PACK, Product Code 7903    f) COMFORT BATH 4-PACK, Product Code 7907    g) COMFORT BATH 5-PACK, Product Code 7956    h) BATH CLOTHS 5-PACK, Product Code 7959    i) BATH CLOTHS 8-PACK, Product Code 7982    j) IMPREVA BATH 5-PACK, Product Code 7987    k) IMPREVA BATH 8-PACK, Product Code 7988    l) COMFORT BATH 2-PACK, Product Code 9775    m) ESSENTIAL BATH 8-PACK, Product Code 7800-MC    n) COMFORT BATH 2-PACK, Product Code 9702-P    a) Lot Numbers 46651, 47524, 49247, 49782, 50894, 50899, 50904, 51181, 52169, 53283, 54171, 54956, 55721, and 56302.    b) Lot Numbers 47851, 47880, 47940, 48497, 51512, 52339, 52381, 52386, 52424,   53200, 54026, 54852, 55337, and 55739.    No expiration dates.
Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15
Superpotent Drug: Failure of assay specifications in the capsule.
Stryker Instruments Div. of Stryker Corporation
US Nationwide in the states of  RI, WA, CA, CO, WI,FL, ID, ND, MD,TX      Foreign: Australia, New Zealand, Netherlands, France, Italy
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090    Product Usage:  Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)
Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.
Florfenicol Mometasone Furoate Terbinafine HCl Otic Solution Claro (15mg/mL Florfenicol, 2.0mg/mL Mometasone Furoate, and 13.3mg/mL Terbinafine HCl), packaged in a tube with foil seal which is in a blister package, most responsible firm name on the label is: Bayer Healthcare LLC, Animal Health Division, Shawnee Mission, Kansas 66201 USA.
Multiple complaints for leaking tubes within the blister packing.
Worldwide Distribution: US (nationwide) to CA and countries of:  Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
Willy Rusch GmbH Tracheostomy Tube Set    Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
The connector may disconnect from the tracheostomy tube during use.
Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches; Net Wt. 1 lb. 0.5 OZ. ; Bimbo Bakeries USA, Inc.; PO #976, Horsham, PA 19044. Best By: October 8, 2016/3098; UPC: 7203002111;    Entenmann's Little Bites Chocolate Chip Muffins; 20 Muffins, 5 Pouches; Net Wt. 8.25 OZ. ; Bimbo Bakeries USA, Inc.; Horsham, PA 19044. Best By: October 8 2016/3098; UPC: 7203001353
10 pouch - 14814 boxes; 5 pouch - 305,772 boxes
Presence of plastic in muffins and brownies.
Entenmann's Little Bites Fudge Brownies - 20 muffins, 5 Pouches; Net Wt. 9.75 OZ.; Bimbo Bakeries USA, Inc., Horsham, PA 19044; Best By: October 8, 2016/3098; UPC: 7203001342
Entenmann's Little Bites Variety - 20 pouches labeled for resale  10 Chocolate Chip; 5 Blueberry; 5 Fudge Brownie;  Net Wt 2 lbs.;  Distributed by: Entenmann's Inc., General Offices, PO #976, Horsham, PA 19044.  Best by: September 24, 2016/ 3098;  UPC:7203001799
Worldwide Distribution - US Distribution and to the countries of :  Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
Cytoplast Titanium-Reinforced Posterior Singles Membrane     A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
The device has the potential to be packaged in the wrong product box.
American Red Cross Blood Services Appalachian Region
Blood and Blood Products for Reprocessing
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, for which the sterility may have been compromised, were distributed.
CADstream software      Product Usage:  CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
844 sites potentially have the affected versions
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100    The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
1,200 Activators (120 boxes of 10 units)
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Washington, Oregon and California New Seasons Markets
New Seasons Markets is recalling their brand name Almond Butter due to a labeling error.  Some of the jars labeled Almond Butter actually contain Peanut Butter.
BEST BY 06/16/2017, BEST BY 08/15/2017, and BEST BY 08/30/2017.    The 08/15/2017 lot was added to the recall on 9/13/16, after initiation.  Press release contained all three lot codes.
Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.
Skintact Electrodes for Defibrillation, DF29N.    Product Usage:  Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring.  The device is non-sterile and for single use only.
There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all.  This may cause a situation in which a patient, who is in a life threatening condition and requires a  defibrillation shock, cannot be treated in good time.
6 Five, Rice Noodles, Keep Refrigerated, Ingredients: Rice flour, water, salt and corn oil.  Weight: 12 oz, Manufactured by: Mei Shun Noodle Inc, 610 W. 26th Street Chicago IL 60613, (312) 842-6500. Noodles on styrofoam tray visible through clear plastic wrap.
Undeclared shrimp, soybean oil and green onions in fresh rice noodles.
No batch, serial or lot numbers available on the packaging.
Product was found to have an elevated pH level.
US Nationwide.  The product was distributed to the following states: IN, TX, VA
National Foods Packaging Chicken Base in 25 lb white poly-lined paper bags
Product contains a spice which was tested and found to contain elevated levels of lead.
Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined bags
National Foods Packaging Low Sodium Chicken Base in 50 lb white poly-lined paper bags
Randox Lipase (Colorimetric)    Product Usage:  A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides.   A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.
Catalogue number:      LI3837, LI7979, LI8050, LI8361
Philips Electronics North  America Corporation
Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy,  Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain  Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz)  Product Number: 865351   Worldwide Except USA    Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591    Exchange part:  453564262531  453564262551  453564262571  453564262591  453564615351  453564615371  453564467761 (Korea)  453564467781 (Korea)  453564451791 (Japan, Taiwan, Indonesia)  453564451811 (Japan, Taiwan, Indonesia)  453564467821 (Mexico)  453564467841 (China)  453564467861 (China)  Worldwide except for the USA  SW Revisions: B.05.28, B.05.29, and B.05.32  	  Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g  Product Number: 865352    Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591    Exchange part:  453564262531  453564262551  453564262571  453564262591  453564615351  453564615371  453564467761 (Korea)  453564467781 (Korea)  453564451791 (Japan, Taiwan, Indonesia)  453564451811 (Japan, Taiwan, Indonesia)  453564467821 (Mexico)  453564467841 (China)  453564467861 (China)    Worldwide   SW Revisions: B.05.28, B.05.29, and B.05.32   Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz)    Product Number: 865350   Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591  USA only  SW Revisions: B.05.28, B.05.29, and B.05.32   Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
US Distribution to states of: MD,TX, FL, GA, VA and PA.
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK  Pin, Fixation, Smooth    A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.
The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins.  If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.
Contents of the package do not match the product labeling.  Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM  Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM  Risks:  Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure.  As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
Item Number  184108  Lot Number  183410  Exp. 8/27/2025
Worldwide Distribution -  USA (nationwide) Distribution.  Foreign/military/government distribution was also made.
CADstream software.  The firm name on the label is Merge Healthcare, Hartland, WI.
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display.  This may result in incorrect patient follow-up.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L)    Product Usage:  When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Worldwide Distribution: US (nationwide) including Puerto Rico and country of Italy.
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
Vascular Solutions is recalling Twin-Pass dual access catheters  because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.
Dual Access Catheter, model 5230.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
West TN Regional Blood Ctr, Inc dba Lifeline Blood Services
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Becton, Dickinson and Company, BD Biosciences
Nationwide Distribution to CA, MN, OH and TX.
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
Lot number: 5348570; Expiration Date: 31 July 2017
Lot number: HBL-115-165, serial numbers 47460959 and 47460980;  Lot number: HBL-116-014 - all serial numbers;  Lot number : HBL-116-040 - 15 systems shipped prior to recall
Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain  circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd.
Environmental samples collected by the Food and Drug Administration revealed the presence of Listeria monocytogenes which has the potential to contaminate food products.
Del Monte Research Center - Walnut Creek
US distribution only to AL, AR, CO, IL, MD, MO, MS, FL, GA, KS, KY, LA, OK, PA, NC, SC, TN, TX, UT, VA, WI, WV.
Allens East Texas Fair Brand, Tiny Tender Field Peas with snaps;  NET.WT. 6 lbs. 15 oz.. (3.15kg)    UPC 0 34700 623214 8  Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250  USA;  UPC 0 34700 63213 1
15, 859 cases (6 cans per case) total, all varieties
Customer complaint of finding crawfish parts in green beans initiated this recall for approximately 15,000 cases of 106 oz. metal cans of green beans or  field peas with snaps sold under various brand names.
Lot Number  615383  Best By Date  06 01 19
Cut Green Beans packed under brand names of:    Allens Cut Green Beans (Ejotes Cortados Lago Azul)  Blue Lake .  Allens Cracker Barrel Label (Both labels have same UPC # - different sodium content - 140 mg  for Allens Cut Green Beans and 250 for Cracker Barrel label  Peso Neto: 6 lbs 10 oz. (3.00 kg)  UPC 0 34700 01224 7;  Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250  USA;    Monarch Blue Lake Green Beans (De Primera, Lago Azul Ejotes Cortados, Tamano 4);  Peso Neto 6 lb. 10 oz. (3 kg)  UPC 7 58108 01041 3    Monarch Cut Green Beans mixed Sieve;  NET WT. 6 lb. 10 oz. (3.00kg);  UPC: 7 58108 01048 2  Distributed by US Foods, Inc. Rosemont, IL 60018;    SYSCO  Reliance Green Beans (Ejotes),  Cut Mix Sieve;  NET WT.  6 lb. 10 oz. (300 kg)  UPC 0 74865 12172 9  SYSCO Green Beans, Mixed & Short Cuts;  NET. WT. 6 lb. 10 oz. (3.00 kg)  UPC: 0 74865 12175 0;  Distributed by Sysco Corporation, Houston, TX    Silver Source Short Cut Green Beans;  NET WT. 6 lb. 10 oz. (3.00 kg)  UPC 8 06795 02895 9  Distributed by Performance Food Group, Richmond, VA 23238
PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7657-56.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7658-56.
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7656-56.
Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland
Lot number: L1615123  Expiration Date: April 11,2017
Fresh Express American Salad, 11 oz., Product Code G264A12B, Use-By Date OCT 05
Fresh Express American had inadvertently inserted incorrect condiment kits in some bags.
Lifesouth Community Blood Centers - Montgomery Region
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
distributed at Fred Meyer stores in in Alaska, Idaho, Oregon and Washington.
All Sell by Dates of 9/29/2016 or before.  BGT wraps are disposed of after one day if they do not sell in the service case at deli department.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
King Henry is recalling King Henry's Gummy Frogs because they may contain undeclared colors (FD&C Yellow #6, Red #40).
King Henry is recalling King Henry's Gummy Frogs because they may contain undeclared colors (FD&C Yellow #6, Yellow #5, Red #40).
Nationwide U.S. distribution    Foreign distribution to the following; United Arab Emirates, Argentina, Australia, Brazil, Chile, China, Costa Rica, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Greece, Guatemala, Indonesia, India, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Kazakhstan, Lebanon, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Quatar, Russia, Saudi Arabia, Sweden, Thailand, Turkey, Taiwan, Vietnam, South Africa, and Canada.
LABType SSO Typing Tests    Model No.:  RSSO2B1, RSO2B1T, RSSOH2B1,  RSOH2B1T, RSSOH2B1X, RSSO2Q,  RSSO2QX, RSO2QT, RSSOMICA,  RSSO1S4, RSO1S4T, RSSOX2B1
HLA test kits containing lot specific user documents, misbranded with incorrect allele specificity  information, were distributed.
Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
Fusion Workstation.; Indicated for the transmission and review of radiological images.
13 sites potentially hae the affected version
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.