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
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutic...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharm...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmac...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIVACAINE HCL [10ML] CMC 80MG/5MG/ML INJ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM 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
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceuti...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA Use, Shake Wel...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 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
Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 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
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceu...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/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
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 West...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single ...
Injectable Drugs·0 affected·Jan 15, 2020
RecallFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 We...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 19...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceuti...
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 [2ML] 6MG/ML INJ SUSP, For I...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only,...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-do...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10...
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 [5ML] 7MG/ML INJ SUSP, For I...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 19...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Teleflex Medical Inc
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Medical Devices·1,764 affected·Jan 13, 2020
High RiskFDA
Stryker Corporation
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Medical Devices·26,298 affected·Jan 7, 2020
High RiskFDA
Medline Industries Inc
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10...
Medical Devices·500 affected·Jan 7, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single U...
Medical Devices·2,050 affected·Jan 3, 2020
High RiskFDA
Zimmer Surgical Inc
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889...
Medical Devices·58 affected·Jan 3, 2020
High RiskFDA
Ethicon, Inc.
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Surgical Devices·23,688 affected·Jan 3, 2020
High RiskFDA
Smith & Nephew, Inc.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Medical Devices·82 affected·Dec 30, 2019
High RiskFDA
Assurance Infusion
LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·4 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
Drugs·2 affected·Dec 20, 2019