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High RiskFDA
Publix Super Markets, Inc.
Publix Steam in Bag Butternut Brussels Pecan
Dairy·585 affected·Jan 14, 2021
High RiskFDA
Covidien Llc
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias v...
Medical Devices·129 affected·Jan 13, 2021
High RiskFDA
Bemer Int. Ag
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC)...
Medical Devices·197,724 affected·Jan 13, 2021
High RiskFDA
Shent Usa, Inc.
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devic...
Medical Devices·85 affected·Jan 12, 2021
High RiskFDA
Shent Usa, Inc.
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through ...
Medical Devices·47 affected·Jan 12, 2021
High RiskFDA
Natus Manufacturing Limited
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cere...
Medical Devices·7 affected·Jan 12, 2021
High RiskFDA
Khee Trading, Inc.
Frozen Tuna Ground Meat - Khee Trading Brand Product of Vietnam 22 Lb. Cartons (2 x 11 lb.)
Meat & Poultry·189 affected·Jan 11, 2021
High RiskFDA
C.r. Bard, Inc.
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Surgical Devices·9,800 affected·Jan 11, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27...
Medical Devices·22,528 affected·Jan 11, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA S...
Medical Devices·20,817 affected·Jan 11, 2021
High RiskFDA
Ecolab Inc
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during v...
Medical Devices·132 affected·Jan 11, 2021
High RiskFDA
Lumiradx
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test ...
Respiratory Devices·3,274,272 affected·Jan 11, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL ...
Medical Devices·2,911 affected·Jan 11, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Squash Planks, 21 Ounces, in a PET Clamshell, UPC 8 13055 01272 6
Food·226 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Butternut Squash Noodles 12 oz.(340g); UPC 8 13055 01749 3, 8 13055 01864 3
Dairy·135 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Own Brands , Butternut Squash Noodles, 12 Ounces, in a PET Clamshell, UPC 6 88267 17259 5
Dairy·526 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Own Brands , Squash Noodle Medley, 20 Ounces, in a PET Clamshell, UPC 6 88267 18585 4
Food·1,183 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Butternut Squash Chunks, 12, 20, 24, 40 Ounces and 2.5 lbs. in a PET Clamshell, 2 per case, 4 per case, 6 per case . UPC: 8 1...
Dairy·427 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Autumn Squash Medley, 16 Ounces, in a PET Clamshell, UPC 8 13055 01115 6
Food·105 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Veggie Rice Blend, 15 Ounces, in a stand-up steam pouch with 'grab & steam' printed on the header, UPC 8 13055 01014 2
Food·33 affected·Jan 10, 2021
High RiskFDA
Lancaster Foods Llc
Lancaster Squash Noodle Medley, 20 Ounces, in a PET Clamshell, UPC 8 13055 01836 0
Food·229 affected·Jan 10, 2021
High RiskFDA
Taro Pharmaceuticals U.s.a., Inc.
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: ...
Oral Drugs·44,256 affected·Jan 8, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Medical Devices·60 affected·Jan 8, 2021
High RiskFDA
Blue Stone Import Usa Inc
SAMYANG Buldak Hot Chicken Flavor Sauce, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
Meat & Poultry·950 affected·Jan 7, 2021
High RiskFDA
Blue Stone Import Usa Inc
SAMYANG Buldak Hot Chicken Flavor Sauce - Carbonara, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
Meat & Poultry·450 affected·Jan 7, 2021
High RiskFDA
American Health Packaging
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by...
Oral Drugs·1,948 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ba...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Baxter Healthcare Corporation
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numb...
Medical Devices·2,314 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus" Chemo Prep & Admin Kit, CT4025
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Dlc Laboratories, Inc
Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laborat...
Topical Drugs·86,297 affected·Jan 6, 2021
High RiskFDA
Respironics California, Llc
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used o...
Respiratory Devices·94 affected·Jan 6, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li...
Diagnostic Devices·1,214 affected·Jan 6, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Klein s Cookies and Cream Bulk Packaged in a 3 gallon paper drum.
Dairy·665 affected·Jan 5, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Klein s Vanilla Ice Cream. Packaged in a 3 gallon paper drum.
Dairy·502 affected·Jan 5, 2021
High RiskFDA
Weis Markets, Inc., Ice Cream Division
Weis Quality Cookies and Cream Ice Cream (48oz). Packaged in a squround paper container with a UPC of 041497-01253.
Dairy·10,869 affected·Jan 5, 2021
High RiskFDA
Ittella International, Llc
Tattooed Chef Plant-Based Sausage Breakfast Bowl Frozen 18-month shelf life Box Net wt. 40oz (1.13kg) UPC: 850015982569 Packed for:...
Frozen Food·12,213 affected·Jan 4, 2021
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, In...
Oral Drugs·6,958 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatme...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal in...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within th...
Surgical Devices·7,400,000 affected·Jan 4, 2021