Worldwide Distribution - US (nationwide) and Canada
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids.  List number 16027.  Note that Hospira retired this pump June 30, 2015.  The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes.  Delay or interruption of therapy.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids.  List number 16026.  Note that Hospira retired this pump June 30, 2015.  The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952
Sampling analysis revealed the product contains undeclared colors (FD&C Red #3 and Red #40).
Beirut Lift Turnip Pickles   Imported & Distributed By: Baroody Import Inc. 1500 B Main Ave. -Clifton, NJ 07011 Tel: 973.3404832    700 g - UPC 642036014141  2 kg - UPC 642036014219  10 kg - UPC
700 g - 5,580 containers; 2 kg - 1200 containers; 10 kg- 50 pails
Beirut Lift Turnip Pickles contain undeclared beet root red color.
no lot codes    dates of distribution:  3/11/2015-8/12/2015
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Domestic: Nationwide in USA; Internationally: Canada
Products were recalled due to the potential presence of plastic foreign material.
Refrigerated, Ready to Eat Pickles Half Sour packaged in 18 Lb. bulk white plastic bucket labeled in part ***204062**PICKLES HALF SOUR BY LB***
Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes.
Lot code in black ink on label: 3/8 & 3/15
Refrigerated, ready-to-eat sour pickles packaged in a 18 Lb. bulk white plastic bucket labeled in part ***204112**SOUR PICKLES BY LB***
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 10.9 oz. (310g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil Forelka Style**Net Wt. 10.0 oz. (310g)** UPC # 825512 004915
Refrigerated, Ready to Eat Herring Ivasi packaged in   Lb. bulk white plastic bucket labeled in part ***204183**HERRING IVASI BY PC***
Refrigerated, Ready to Eat Holland Herring in Oil under firms brand name FRESH SEAFOOD packaged in a 24 oz. (680g) plastic retail container labeled in part ***FRESH**SEAFOOD**Holland Herring in Oil**Net Wt. 24 oz. (680g)*** UPC # 825512008128
Refrigerated, Ready to Eat Mushrooms Maslyata Korolevskie packaged in 4.5  Lb. bulk white plastic bucket labeled in part ***204394**MUSHROOMS MASLYATA KOROLEVSKIE POD RUMOCHKU BY LB ***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a   plastic bucket labeled in part ***204883**HERRING DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Cherry Tomatoes packaged in 15 Lb. bulk white plastic bucket labeled in part ***204017**CHERRY TOMATOES BY LB***
Lot code in black ink on label: 3/10 & 3/17
Refrigerated, ready-to-eat red tomatoes packaged in a 15 Lb. bulk white plastic bucket labeled in part ***204061**RED TOMATOES BY LB***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a    plastic bucket labeled in part ***204709**HERRING FILLET SUPER DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Pacific Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004946
Refrigerated, ready-to-eat SOUR CABBAGE BY LB packaged in a 25 Lb. bulk white plastic bucket labeled in part ***204023**MARINATED CABBAGE BY LB***
Refrigerated, Ready to Cabbage Boyarskaya packaged in 25 Lb. bulk white plastic bucket labeled in part ***204259**CABBAGE BOYARSKAYA BY LB***
Lot code in black ink on label: 3/9, 3/11, & 3/16
Refrigerated, Ready to Eat Herring Super Dunayskaya packaged in clear vacuum package labeled in part ***204450**HERRING SUPER DUNAYSKAYA IN VACUUM BY PC***
Refrigerated, ready-to-eat Korean Carrot Salad packaged in bulk 25 Lb. white plastic bucket labeled in part ***204034**SALAD KOREAN CARROT BY LB***
Refrigerated, Ready to Eat Salad Izolda packaged in 25 Lb. bulk white plastic bucket labeled in part ***204129**SALAD IZOLDA BY LB***
Refrigerated, Ready to Eat Marinated Shitake Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204138**HERRING IVASI BY PC***
Refrigerated, Ready to Eat Herring in Spicy Brine under firms brand name FRESH SEAFOOD packaged in a 46 oz. (1275g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring in Spicy Brine**Net Wt. 46 oz. (1275g)***UPC # 825512008166
Refrigerated, Ready to Eat Marinated Opyata Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204136**MARINATED OPYATA MUSHROOMS BY LB ***
Refrigerated, Ready to Eat Herring Fillets In Oil under firms brand name FRESH SEAFOOD packaged in a 28.2oz. (800g) plastic retail container  labeled in part ***FRESH**SEAFOOD**SUPER DUNAYSKAYA**Herring Fillets in Oil**Net Wt. 28.2 oz. (800g)
Refrigerated, Ready to Eat Salad Pikantniy packaged in 25 Lb. bulk white plastic bucket labeled in part ***204143**SALAD PIKANTNIY BY LB***
Lot code in black ink on label: 3/9 & 3/16
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204311**HERRING SUPER DUNAYSKAYA BY PC***
Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a   plastic bucket labeled in part ***204857**HERRING NORWAY SUPER JUMBO BY PC***
Refrigerated, Ready to Eat Herring Fillets Matjes under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet Matjes**Net Wt. 16.2 oz. (460g)*** UPC # 825512004960
Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004984
Refrigerated, Ready to Eat Red Cabbage packaged in 18 Lb. bulk white plastic bucket labeled in part ***204070**RED CABBAGE BY LB***
Refrigerated, ready-to-eat marinated oyster mushrooms packaged in a 4.5 Lb. small clear plastic bucket labeled in part ***204139**MARINATED OYSTERS BY LB***
Refrigerated, ready-to-eat marinated apples packaged in 15 Lb. bulk white plastic bucket labeled in part ***204022**MARINATED APPLES BY LB***
Refrigerated, Ready to Eat Herring Fillets in Oil Lightly Salted under firms brand name FRESH SEAFOOD packaged in a 16 oz. (454g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillets in Oil Lightly Salted**Net Wt. 16 oz. (454g)***UPC # 825512014044
Trader Joe's Chocolate Orange Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847162
Trader Joe's Chocolate Raspberry Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847122
Trader Joe's Co. is recalling all codes of Trader Joe's Chocolate Orange Sticks and Trader Joe's Chocolate Raspberry Sticks because the products may contain more than the stated traces of milk on the label.
Misty Fjord Lox, vacuum packed in 4 oz serving size packs.
Misty Fjord Seafoods LLC is recalling Lemon Pepper smoked salmon, Maple smoked salmon and Lox salmon due to the potential to be contaminated with Listeria Monocytogenes.
Misty Fjord Maple Smoked Salmon, vacuum sealed 6 oz plastic packs.
Misty Fjord Lemon Pepper Smoked Salmon, vacuum sealed 6 oz plastic packs.
Coverage is predominately the Midwest, specifically Nebraska, Iowa, Kansas, Colorado and South Dakota.  Smaller concentration of stores in ND, WY, UT, OK, TX, MN and WI.
Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case)
3617 12-8oz. bottle cases, 27218 12-16oz. bottle cases, 22241 12-32oz. bottle cases, and 9082 4-gallon cases
Gallons with Best By dates between 6/16/16 and 10/11/16 are recalled.
SOFiT Protein Plus Sunflower Seeds Sea Salt; Seeds covered by a crunchy protein shell:  NET WT. 1 OZ.
The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1.    Products have the potential to be contaminated with Listeria monocytogenes.
SOFiT Protein Plus Pumpkin Seeds Sesame Garlic, Seeds covered by a crunchy protein shell:  NET WT. 1 OZ.
The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1.     Products have the potential to be contaminated with Listeria monocytogenes.
SOFiT Protein Plus Almonds Jalapeno Garlic, whole almonds covered by a crunchy protein shell:  NET WT. 1 OZ.
Muscle Milk Pro Series 40 14 oz., 40 g protein;  Going Bananas    UPC (case):  8-76063-00294-3;    UPC (unit):  8-76063-00284-4
35734 cases shipped, 12 x 14 oz. per case
Products recalled due to premature spoilage (swelled containers & foul odor).
Muscle Milk Pro Series 40 14 oz;, 40 g protein  Crushin' Cookies.    UPC (case): 8-76063-00293-6;    UPC (unit): 8-76063-00283-7
HP Hood Lot numbers:E15336, A16023, F16107.
Muscle Milk 14 oz  Chocolate, 25 g protein.    UPC (case):  8-76063-00221-9;    UPC (unit):  8-76063-00201-1
Muscle Milk 14 oz. 25 g protein  Caramel Kick    UPC (case): 8-76063-00214-1;    UPC (unit):  8-76063-00219-6
Muscle Milk 10 oz. 18 g protein.  Sold in 4 packs  Vanilla Creme    UPC (case): 8-76063-00272-1;    UPC (unit): 8-76063-00262-2
HP Hood Lot numbers: A16018, B16019, A16112.
Muscle Milk 10 oz. 18 grams protein. Sold in 4 packs  Chocolate;    UPC (case):  8-76063-00271-4;    UPC (unit):  8-76063-00261-5
7216 cases - 24 units per case - six-4 packs
Muscle Milk Pro Series 40 14 oz.;  40 g protein  Intense Vanilla    UPC Case: 8-76063-00291-2;    UPC Unit: 8-76063-00281-3
21561 cases shipped; 12 x 14 oz. units per case
FitPro Go! 14oz   Chocolate; 35 g protein    UPC Case: 8-5418200328-7;    UPC Unit: 8-5418200324-9
Muscle Milk 14 oz., 25 g protein  Strawberry;    UPC (case): 8-76063-00229-5;    UPC (unit):  8-76063-00209-7
Muscle Milk Pro Series 40, 14 oz.. 40 g protein;  Knock Out Chocolate    UPC (case):  8-76063-00290-5;    UPC (unit):  8-76063-00280-6
Muscle Milk 100 Calorie 14 oz  Chocolate     UPC (case):  8-76063-00575-3;    UPC (unit):  8-76063-00565-4
Muscle Milk 14 oz, 25 g protein.  Vanilla Creme    UPC (case):  8-76063-00222-6;    UPC (unit):  8-76063-00202-8
FitPro Go! 14oz, 35 g protein   Chocolate Chip Cookies    UPC(Case): 8-5418200338-6;    UPC Unit: 8-5418200325-6
FitPro Go! 14oz   Strawberry;  35g protein    UPC (Case): 8-5418200329-4;    UPC (Individual): 8-5418200326-3
14024 cases shipped, 12 x 14 oz. containers
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC,  STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.
Whitacre Spinal Needle, TW  B02H077D 1-Jun-2015  B03H106D 1-Jun-2015
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
42,740 cartons (24 count carton from 7 total lots)
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI.    Product was also shipped to the following countries: Poland and Switzerland
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip  Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
There is a potential for a component failure of the device which could necessitate medical intervention.
Model Numbers: PRO235, PRO240, PRO245 and PRO250    Lot Numbers: 65622 to 66773
Distributed to direct accounts in the state Missouri.
White Wine & Garlic Wine Drizzle, packaged in 5 oz and 8 oz glass bottles, www.winedrizzle.com, Higginsville, MO 64037
Drizzle product contains undeclared milk, a subingredient of a listed ingredient: Parmesan cheese
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.
Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
Estradiol 12.5 mg Pellet,  Compounded by: Wells Pharmacy Network
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone Cholesterol ,100 mg Pellet,  Compounded by: Wells Pharmacy Network
Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network
VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia
Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz
Baked bread products may contain foreign material-plastic pieces
Market Basket Plain Sub (Grinder) rolls-
Market Basket Bulkie Rolls- Plain, Wheat packaged 15.6 oz
, packaged 16 oz. 18, oz, 20 oz, 25 oz, 29 oz
Koffee Kup Hoogie Rolls- Wheat, Sourdough, Potatoe packaged 15 oz and 15.6 and 17 oz
Big Y Plain Grinders- Enriched wheat  and Enriched White packaged 15 oz
Koffee Kup Kaiser Rolls: Egg,  Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz
Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
Koffee Kup Bar-B-Que Sweet Buns- Plain, Corn, Sesame Seed and Wheat w/Oat Topping, packaged 8 oz.
Koffee Kup  Potatoe Hamburger Buns, Plain and Seeded, 8 pk
Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA,  and VA    Replcement cylinders wre distributed
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable.        Product Usage:  The cylinders are used to lock the surgical table in place.
4 surgical tables with defective floor locking cylinders were distributed. Each table contains  3 cylinders for a total of 12 cylinders.
ring which may cause the cylinder to leak.
Lot Codes for the four (4) model 7300 Surgical Tables   TFX-1653, TFX1654, TFX1655, TFX1656
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118.     Product Usage:  The cylinders are used to lock the surgical table in place.
Lot code of the replacement cylinders, 2016-02-01
On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows.
On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
46,472 unit dose blister cards (10 cards of 10 tablets each)
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only,  Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Worldwide Distribution - US Nationwide  Foreign:  Canada:  Andorra  Austria  Belgium  Czech Republic  Denmark  Finland  France  Germany  Greece  Ireland  Israel  Italy  Latvia  Luxembourg  Monaco  Netherlands  Norway  Poland  Portugal  Russian Federation   Saudi Arabia  Slovenia  South Africa  Spain  Sweden  Switzerland  United Arab Emirates  United Kingdom
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove   Item Number                                            Description  380789003                           SURE SET SINGLE BASIN PACK  400383006                           MAJOR BASIN PACK  400383007                           MAJOR BASIN PACK  618275004                           BASIN PACK    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
All lot codes in the following:    Item Number                                            Description  380789003                           SURE SET SINGLE BASIN PACK  400383006                           MAJOR BASIN PACK  400383007                           MAJOR BASIN PACK  618275004                           BASIN PACK
Covidien Devon Light Glove packaged in sterile surgical kits  Reference: 31140208    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles
All lot codes in the following kits:  Item Number   Decription  56479 7335-SMC DELIVERY KIT  573208 7519-DHCG SURGI-START KIT  573210 7581-CSD SURGI-START KIT  573310 7417-SSC SURGI-START KIT  573326 7497-HLS MINI-PLUS KIT  573328 7437-NRF SURGI FOOTPACK ASCKIT  573343 7499-88 SURGICAL KIT  573346 7499-TLG SURGICAL KIT  573359 7499-HLW MINI-PLUS KIT  573368 7494-CAB2 SURGICAL KIT  573370 7411-SSI MINI PLUS KIT  573509 7696-GSL-VL SINGLE BASIN KIT  573529 7697-T4E SINGLE BASIN SURGI KI  573558 7665-CPB SINGLE BASIN KIT  573561 7696-KSC SINGLE BASIN KIT  573713 7553-SBT MINI-PLUS KIT  573732 7620-CWA SURGICAL ASC KIT  573741 7667-HMI SURGICAL ASC KIT  573776 7520-BHP SURGICAL ASC KITS  573777 7527-BHB SURGICAL ASC KITS  573798 7496-8KB MINI-PLUS KIT  573799 7516-UNIKB SET-UP KIT  573813 7590-GHF HAND AND FOOT PACK  773501 7692-WIW2 SURGI-START KIT  773701 7600-ESC SURGI-START KIT  31140208 3611 FLEXBL LITE GLOVE 1EA/PKG  31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG  31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG  31141479 K-1842-S STD. MINI-KIT STERILE  31141487 K-1560-S3 STD. MINI KIT STER.  31141495 K-1530-S3 STANDARD MINI-KIT  31141537 K-1940-S STD. MINI KIT STER.  31141552 K-1920-S STANDARD MINI-KIT  31141560 K-1200-S3 STD MINI-KIT  31141578 K-1840-S STD. MINI KIT STER.  31131141602 K-1630-S STD. MINI KIT STER.  31141610 K-1615-S STD. MINI KIT STER.  31141628 K-1614-S STD MINI-KIT  31141651 K-1560-S STD. MINI KIT STERILE  31141669 K-1530-S STD. MINI KIT  31141677 K-1200-S STD. MINI KIT  31141784 K-1960-S STANDARD MINI-KIT  31141859 K-1615-S3 STD MINI-KIT  31141875 K-1940-S3 STD. MINI-KIT STER.  31144507 7519 BUNNY KIT - GENERAL BUNNY  31144879 7815 SURGI-START KIT STERILE  31144895 7614-T4 SURGI-START KIT  31144960 7693-T4 SURGI-START KIT  31144978 7766 SURGI-START KIT  31145025 7496-8 MINI-PLUS KIT - STERILE  31145215 7896 STANDARD SURGI-START KIT  31145231 7897 STD, SURGI-START KIT  31145249 7897-T8 SURGI-START KIT STER  31145298 7896-T8 STANDARD,SURGI START  31145363 7496-88 STANDARD,MINI-PLUS KIT  31145397 7497-8 S
Covidien Devon Light Glove sub-assembly non-sterile  For Kit Packers    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles
All lot codes in the following:  Item Number   Decription  56479 7335-SMC DELIVERY KIT  573208 7519-DHCG SURGI-START KIT  573210 7581-CSD SURGI-START KIT  573310 7417-SSC SURGI-START KIT  573326 7497-HLS MINI-PLUS KIT  573328 7437-NRF SURGI FOOTPACK ASCKIT  573343 7499-88 SURGICAL KIT  573346 7499-TLG SURGICAL KIT  573359 7499-HLW MINI-PLUS KIT  573368 7494-CAB2 SURGICAL KIT  573370 7411-SSI MINI PLUS KIT  573509 7696-GSL-VL SINGLE BASIN KIT  573529 7697-T4E SINGLE BASIN SURGI KI  573558 7665-CPB SINGLE BASIN KIT  573561 7696-KSC SINGLE BASIN KIT  573713 7553-SBT MINI-PLUS KIT  573732 7620-CWA SURGICAL ASC KIT  573741 7667-HMI SURGICAL ASC KIT  573776 7520-BHP SURGICAL ASC KITS  573777 7527-BHB SURGICAL ASC KITS  573798 7496-8KB MINI-PLUS KIT  573799 7516-UNIKB SET-UP KIT  573813 7590-GHF HAND AND FOOT PACK  773501 7692-WIW2 SURGI-START KIT  773701 7600-ESC SURGI-START KIT  31140208 3611 FLEXBL LITE GLOVE 1EA/PKG  31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG  31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG  31141479 K-1842-S STD. MINI-KIT STERILE  31141487 K-1560-S3 STD. MINI KIT STER.  31141495 K-1530-S3 STANDARD MINI-KIT  31141537 K-1940-S STD. MINI KIT STER.  31141552 K-1920-S STANDARD MINI-KIT  31141560 K-1200-S3 STD MINI-KIT  31141578 K-1840-S STD. MINI KIT STER.  31141586 K-1660-S STD. MINI-KIT STER.  31141602 K-1630-S STD. MINI KIT STER.  31141610 K-1615-S STD. MINI KIT STER.  31141628 K-1614-S STD MINI-KIT  31141651 K-1560-S STD. MINI KIT STERILE  31141669 K-1530-S STD. MINI KIT  31141677 K-1200-S STD. MINI KIT  31141784 K-1960-S STANDARD MINI-KIT  31141859 K-1615-S3 STD MINI-KIT  31141875 K-1940-S3 STD. MINI-KIT STER.  31144507 7519 BUNNY KIT - GENERAL BUNNY  31144879 7815 SURGI-START KIT STERILE  31144895 7614-T4 SURGI-START KIT  31144960 7693-T4 SURGI-START KIT  31144978 7766 SURGI-START KIT  31145025 7496-8 MINI-PLUS KIT - STERILE  31145215 7896 STANDARD SURGI-START KIT  31145231 7897 STD, SURGI-START KIT  31145249 7897-T8 SURGI-START KIT STER  31145298 7896-T8 STANDARD,SURGI START  31145363 7496-88 STANDARD,M
Roche COBAS INTEGRA c111  Analyzer, Chemistry (Photometric, Discrete), for clinical use    Product Usage:  The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Alligator Retrieval Device  The device is intended for use in the peripheral and neurovasculature for foreign body removal.
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter  Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature.
Pipeline Embolization Device (Pipeline Classic)  The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements.
NC, MA, NJ, WI, IA, one customer in England
Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02
Dietary supplement contains excess amount of fluoride.
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA
Accessory Adapter Part number 600525A0    Product Usage:  designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife  Size: Working Length 1.8M Maximum OD 2.6mm.      Product Usage:  The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
SB  Knife -Electrosurgical Knife, Sterile  Size:  Working Length 2.3M Maximum OD 2.6mm.    Product Usage:  The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
132 worldwide distribution (98) of those units in US
Lot# 01160568 . Lot#02160586, (no products shipped from this lot)  Lot# 07160639 -150
Nationwide. No VA/govt/military, Canadian, or other foreign consignees.
Professional Botanicals MealPlex (756 grams) and Veo Natural Pearl 3.0 (378 grams) Ultimate Meal Drinks in Plastic Tub Containers.  Dietary Supplement.
Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen.
U.S. distribution to the following; AZ, MN and MO.
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters    Model Numbers:   401940, 402004    UPC Code:  00885825007409  00885825007744    Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes.    Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
The EP Catheters may be mislabeled for French size during reprocessing.
Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of  Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799    Product Usage:  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
Trumpf has identified six incidents of pinched cables.
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634      Product Usage:  The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Potential presence of particulate matter on the blood side of the dialyzer
ARCHITECT Lactic Acid Part # 09D891T21    The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081    The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
Contract manufacturer packaged an incorrect sheath with the product.  Packaged 30Fr instead of 24Fr.
Lot BMZCE039, Expiration Date 2018-12-31
Bindi Fantasia nel dessert, 7982 Coconut Gran Sorbetto, 1.24 Gal (4.8L), UPC 8 15073 01326 6, Distributed by: Bindi North America, Kearny, NJ 07032
27 cases (Lot #6211) and 6 cases (Lot #6265)
Product recalled due to undeclared milk allergen (sodium caseinate).
Lot #6211 with best before date 07/29/18 and Lot #6265 with best before date 09/21/18
Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
NRG Transseptal Needle and NRG RF Transseptal Kit.    Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0.     The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch.    Used to create an atrial septal defect  in the heart.
The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG  Transseptal Needle.
US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110    product Usage:  The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action.  Image 1.
There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes   are assigned to this part number.  The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device
AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.
Fruit 66 Strawberry Melon, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00116.
1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.
Fruit 66 Tropical Punch, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00108.
Fruit 66 Passion Fruit Mango, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00109.
Fruit 66 Mixed Berry, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00117.
SOMATOM Definition Flash  system, x-ray, tomography, computed
Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.
SOMATOM Definition AS  system, x-ray, tomography, computed
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
TBS iNsight Version v.3.0.1    Product Usage:  TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.
Brownwood Farms Michigan Cherry Preserves  12oz glass bottles and 1 gallon.  Private labels:  Art's Tavern (Cherry Preserves 12oz).
Products contain milk not declared on the label.
All product on market, any best by date prior to 9/28/2018.
Brownwood Farms Cherry Raspberry Preserves  12oz glass bottles and 1 gallon.
Brownwood Farms America's Original Cherry Butter   12oz and 22oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Cherry Butter 12oz).  Bowers Harbor Vineyards (Cherry Butter 12oz).  Crossroads (10oz).  Central Market (16oz).
Brownwood Farms Jalapeno Cherry Butter  12oz and 20oz glass bottles and 1 gallon.  Private labels:  Kimmel Orchard & Vineyard (Jalapeno Cherry Butter 12oz).  Benjamin Twiggs (Cherry Pepper Jam 10oz).  Central Market (16oz).
Brownwood Farms Pear & Cinnamon Preserves  10oz glass bottles and 1 gallon.
Brownwood Farms Strawberry Preserves  12oz glass bottles and 1 gallon.  Private labels:  Art's Tavern (Strawberry Preserves 12oz).
Krispy Kreme Doughnuts Original Glazed Doughnuts, 6 count and 12 count boxes.
Possible piece of plastic in the product.
N/A - Product produced on October 20, 2016
Walnuts undeclared on outer retail unit carton.
Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.)
Pieces of plastic and metal discovered within product.
Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.
LMA MADomizer, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
LMA MADgic, Atomization Device with 3mL Syringe, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE LONG, 10 Boxes of 25 units each    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADdy, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE SHORT    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.