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
Medline Industries Inc
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Medical Devices·1,541,532 affected·Feb 10, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This d...
Cardiac Devices·669 affected·Feb 6, 2020
High RiskFDA
Pfizer Inc.
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramus...
Injectable Drugs·38,676 affected·Feb 3, 2020
High RiskFDA
Cardinal Health 200, Llc
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January...
Surgical Devices·2,161,526 affected·Jan 31, 2020
High RiskFDA
Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Medical Devices·122 affected·Jan 21, 2020
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
FlipCutter III Drill
Medical Devices·6,625 affected·Jan 20, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50...
Medical Devices·2,130 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 5...
Medical Devices·4,710 affected·Jan 17, 2020
High RiskFDA
Beckman Coulter Inc.
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based softwa...
Medical Devices·177 affected·Jan 17, 2020
High RiskFDA
Covidien Llc
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Medical Devices·2,180 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50...
Medical Devices·480 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50...
Medical Devices·2,850 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 8...
Medical Devices·70 affected·Jan 17, 2020
RecallFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply ...
Surgical Devices·4 affected·Jan 16, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Ph...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 1...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. S...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Ax...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutica...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx on...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 3...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal U...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutica...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx onl...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharma...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-d...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Ax...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx o...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutica...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwo...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 199...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 1...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative ...
Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx onl...
Injectable Drugs·0 affected·Jan 15, 2020