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
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-27...
Drugs·12 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164...
Drugs·13 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73...
Drugs·61 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-4...
Drugs·1 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 7...
Drugs·5 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
Drugs·13 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.
Drugs·2 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-02...
Drugs·4 affected·Oct 15, 2019
High RiskFDA
Implant Direct Sybron Manufacturing Llc
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Medical Implants·78 affected·Oct 11, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·290 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·1,747 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·3,905 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·413 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 ...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourc...
Injectable Drugs·162 affected·Oct 9, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Co...
Drugs·1,047 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pu...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Nextremity Solutions
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating S...
Medical Devices·49 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scien...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus ...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for O...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Baylis Medical Company Inc.
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Baylis Medical Company Inc.
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, ...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Pfizer Inc.
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC ...
Injectable Drugs·17,832 affected·Oct 2, 2019
High RiskFDA
New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
Injectable Drugs·2,981 affected·Oct 1, 2019
High RiskFDA
Akorn, Inc.
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478...
Ophthalmic Drugs·60,176 affected·Sep 20, 2019
High RiskFDA
Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Surgical Devices·464,040 affected·Sep 19, 2019
High RiskFDA
Xodus Medical Inc
Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Surgical Devices·255,000 affected·Sep 19, 2019
High RiskFDA
Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Surgical Devices·460,000 affected·Sep 19, 2019
High RiskFDA
Ra Medical Systems, Inc.
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser ...
Surgical Devices·5,082 affected·Sep 19, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ ...
Ophthalmic Drugs·808 affected·Sep 18, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 50...
Medical Devices·11,389,800 affected·Sep 18, 2019
High RiskFDA
Akorn, Inc.
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Drugs·10,543 affected·Sep 17, 2019
High RiskFDA
Cook Inc.
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for...
Medical Devices·41 affected·Sep 17, 2019
CriticalFDA
Cme America, Llc
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infu...
Medical Devices·69,400 affected·Sep 16, 2019
High RiskFDA
Krs Global Biotechnology, Inc
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boc...
Drugs·10,630 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park ...
Drugs·3,410 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial),...
Drugs·95 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, ...
Drugs·120 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Supplements·6,325 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL),...
Topical Drugs·242 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Co...
Drugs·6,447 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blv...
Drugs·7,685 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 P...
Drugs·602 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL...
Drugs·345 affected·Sep 12, 2019