Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Arthrex, Inc.
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Medical Devices·123 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
Surgical Devices·180 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
Medical Devices·16 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
HENRY SCHEIN, Knee Pack, Item No.570-2908,
Medical Devices·48 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
Medical Devices·24 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Medical Devices·105 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Medical Devices·581 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
STRADIS HEALTHCARE, Breast, Item No.693-276,
Medical Devices·16 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Surgical Devices·10 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
Medical Devices·40 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
Medical Devices·20 affected·Nov 2, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
Medical Devices·100 affected·Nov 2, 2022
High RiskFDA
Nuvasive Specialized Orthopedics, Inc.
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. RE...
Medical Devices·1,873 affected·Nov 1, 2022
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue b...
Surgical Devices·95 affected·Oct 14, 2022
High RiskFDA
Abbott Laboratories
Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Beverages·14,588,544 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lak...
Ophthalmic Drugs·6,273 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured ...
Topical Drugs·36,025 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17...
Ophthalmic Drugs·1,310,324 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest...
Topical Drugs·1,164,171 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn,...
Ophthalmic Drugs·967,075 affected·Oct 13, 2022
High RiskFDA
Medical Action Industries, Inc. 306
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, R...
Medical Devices·24 affected·Oct 12, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 P...
Injectable Drugs·16,006 affected·Oct 11, 2022
High RiskFDA
Hologic, Inc
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Surgical Devices·178 affected·Oct 10, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·40 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Ha...
Drugs·106 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·28 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Ophthalmic Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th ...
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesbu...
Injectable Drugs·242 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Injectable Drugs·10 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·3 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hat...
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·378 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·460 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesbu...
Injectable Drugs·514 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·45 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th A...
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hat...
Drugs·5 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·1 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattie...
Drugs·2 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., ...
Injectable Drugs·800 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·12 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·86 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·2 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs·12 affected·Oct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., H...
Drugs·56 affected·Oct 7, 2022