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High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
Medical Devices·104,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Medical Devices·504,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
Medical Devices·36,020 affected·Oct 6, 2022
High RiskFDA
Aurobindo Pharma Usa Inc.
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-H...
Oral Drugs·9,504 affected·Oct 5, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Medical Devices·17,700 affected·Oct 4, 2022
High RiskFDA
Kabobs Acquisition Inc.
BRIE EN CROUTE WITH RASPBERRY
Produce·25 affected·Oct 3, 2022
High RiskFDA
Jlm Manufacturing Llc
JLM Sesame Sticks Mix in clear plastic 11oz. tub UPC 094776081646 12 retail units per case
Food·307 affected·Oct 3, 2022
High RiskFDA
Rama Food Manufacture Corp
Pad Thai Noodles Rama Foods (Brand) Net Wt.: 16 oz (1 LB) LDPE (Vacuum sealed package) 30 Pkgs./Per case Keep Refrigerated Mfg. date: 09/...
Food·700 affected·Oct 3, 2022
High RiskFDA
Jlm Manufacturing Llc
JLM Sunflower Meat Roasted/Salted in clear plastic 10oz. tubs UPC 760208118135 12 retail units per case
Meat & Poultry·175 affected·Oct 3, 2022
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto...
Medical Devices·1,457 affected·Oct 3, 2022
High RiskFDA
Beckman Coulter, Inc.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Medical Devices·53 affected·Oct 3, 2022
High RiskFDA
Auromedics Pharma Llc
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeto...
Injectable Drugs·11,520 affected·Sep 30, 2022
High RiskFDA
Vistapharm, Inc.
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 666...
Oral Drugs·1,980 affected·Sep 30, 2022
High RiskFDA
Ingenus Pharmaceuticals Llc
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; N...
Inhaled / Nasal Drugs·6,176 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medical Devices·50 affected·Sep 30, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Medical Implants·7 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Medical Devices·60 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Medical Devices·50 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Medical Devices·240 affected·Sep 30, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Medical Devices·1 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Surgical Devices·800 affected·Sep 30, 2022
High RiskFDA
Lemaitre Vascular, Inc.
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewi...
Surgical Devices·72 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Surgical Devices·28 affected·Sep 30, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Medical Devices·1 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Surgical Devices·96 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Surgical Devices·160 affected·Sep 30, 2022
High RiskFDA
Beaver Visitec International, Inc.
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot,...
Medical Devices·150 affected·Sep 30, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Medical Implants·142 affected·Sep 30, 2022
High RiskFDA
Snak King Corporation
16 oz. bags of Trader Joe's Organic Yellow Tortilla Chip Rounds. UPC: 0074-0449 Distributed and Sold exclusively by: Trader Joe's, Mon...
Snacks & Candy·14,412 affected·Sep 29, 2022
High RiskFDA
Cipla
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch...
Drugs·9,041 affected·Sep 29, 2022
High RiskFDA
Kamiya Biomedical Company, Llc
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Diagnostic Devices·165 affected·Sep 28, 2022
High RiskFDA
Teleflex Llc
Pilling Wecksorb Cylindrical Sponges
Medical Devices·1,000 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Medical Devices·409,738 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Medical Devices·414,194 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Medical Devices·129,412 affected·Sep 28, 2022
High RiskFDA
X-nav Technologies, Llc
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P01...
Medical Devices·102 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
Medical Devices·499,997 affected·Sep 28, 2022
High RiskFDA
Pfizer Inc.
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60...
Injectable Drugs·103,150 affected·Sep 27, 2022
High RiskFDA
Synthes (usa) Products Llc
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Medical Implants·96 affected·Sep 27, 2022
High RiskFDA
Auromedics Pharma Llc
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-H...
Injectable Drugs·89,400 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Medical Devices·318 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Medical Devices·16 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
Medical Devices·451 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Medical Devices·265 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
Medical Devices·1,143 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
Medical Devices·483 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
Medical Devices·493 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
Medical Devices·334 affected·Sep 26, 2022