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High RiskFDA
Intuitive Surgical, Inc.
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray...
Medical Devices·160 affected·Oct 7, 2022
CriticalFDA
Bakkavor Usa, Inc
H-E-B Meal Simple Tomato Basil Soup 32 oz. Plastic containers, 6 containers per case Keep Refrigerated.
Produce·1,248 affected·Oct 6, 2022
CriticalFDA
Cuisine Innovations Unlimited, Llc
Earth Grown Vegan Garlic & Herb Falafel NET WT 12 OZ (340g), 12 pieces UPC:4 0991002 24344
Food·31,810 affected·Oct 6, 2022
CriticalFDA
Cuisine Innovations Unlimited, Llc
Earth Grown Vegan Traditional Falafel NET WT 12 OZ (340g), 12 pieces UPC:4 0991002 24337
Food·31,810 affected·Oct 6, 2022
High RiskFDA
Craftology, Llc Dba Dutch Treat Foods
Craftology This Is My Happy Place Handcrafted Pasta Salad 14oz clear plastic clamshell, UPC 8 55034 00649 4, 6 units per wholesale case....
Produce·3,716 affected·Oct 6, 2022
High RiskFDA
Southwest Iowa Renewable Energy Llc
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (50...
Drugs·3,008 affected·Oct 6, 2022
High RiskFDA
Golden State Medical Supply Inc.
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporate...
Oral Drugs·0 affected·Oct 6, 2022
High RiskFDA
Golden State Medical Supply Inc.
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bo...
Oral Drugs·0 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
Medical Devices·769,810 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
Medical Devices·2,779,810 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
Medical Devices·26,160 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
Medical Devices·248,750 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
Medical Devices·17,200 affected·Oct 6, 2022
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP ...
Surgical Devices·715,620 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
Medical Devices·84,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
Medical Devices·14,360 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Medical Devices·43,200 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
Medical Devices·807,720 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Medical Devices·103,000 affected·Oct 6, 2022
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
CriticalFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufac...
Injectable Drugs·2,123,040 affected·Oct 4, 2022
CriticalFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for...
Injectable Drugs·148,920 affected·Oct 4, 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
CriticalFDA
Swiss American Inc
Saint Louis Domestic Brie Wedge, 7oz, saran wrapped, UPC: 041563 263709; Saint Louis Domestic Cut Brie Wedge, variable weight-6lb RD WT, ...
Food·2,701 affected·Sep 30, 2022
CriticalFDA
Whole Foods Market Brand 365, Llc
Zerto Fontal Cheese UPC 20565300000 sliced in store and sold by the pound wrapped in plastic wrap
Dairy·213 affected·Sep 30, 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
CriticalFDA
Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Medical Devices·1,137 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
CriticalFDA
Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Medical Devices·814 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