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
New England Compounding Center
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·165 affected·Sep 26, 2012
CriticalFDA
New England Compounding Center
Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Cent...
Injectable Drugs·5,130 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·7,055 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·8,919 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·54 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compou...
Drugs·56,655 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·3,321 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding C...
Injectable Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate...
Injectable Drugs·0 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
Drugs·0 affected·Sep 26, 2012
CriticalFDA
New England Compounding Center
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center...
Injectable Drugs·23,897 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·2,747 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
Drugs·0 affected·Sep 26, 2012
CriticalFDA
New England Compounding Center
Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Cent...
Injectable Drugs·3,822 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, ...
Drugs·20 affected·Sep 26, 2012
High RiskFDA
New England Compounding Center
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Drugs·10,865 affected·Sep 26, 2012
High RiskFDA
Teleflex Medical
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Me...
Surgical Devices·126 affected·Sep 25, 2012
High RiskFDA
Zimmer, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for e...
Medical Devices·24 affected·Sep 20, 2012
High RiskFDA
Medline Industries Inc
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: Th...
Surgical Devices·18 affected·Sep 20, 2012
High RiskFDA
Zimmer, Inc.
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for de...
Medical Implants·170 affected·Sep 20, 2012
High RiskFDA
Boston Scientific Corporation
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable,...
Surgical Devices·19 affected·Sep 17, 2012
High RiskFDA
Pioneer Surgical Technology, Inc.
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Medical Devices·11 affected·Sep 10, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile...
Medical Devices·488,504 affected·Sep 7, 2012
High RiskFDA
C.r. Bard, Inc., Urological Division
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated...
Surgical Devices·4,032 affected·Sep 7, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV f...
Medical Devices·1,995,040 affected·Sep 7, 2012
High RiskFDA
Greatbatch Medical
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientifi...
Cardiac Devices·787 affected·Sep 6, 2012
High RiskFDA
F. Hoffmann-laroche Ltd.
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, W...
Drugs·42,010 affected·Sep 5, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
Medical Devices·74 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Biolox¿ Option Ceramic Femoral Head System Rx, sterile
Medical Devices·88 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, G...
Medical Devices·164 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx
Medical Devices·228 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
MS-30¿ Distal centralizer, cemented, sterile, Rx
Medical Devices·58 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Original M.E. Mueller" Low Profile Cup Sterile, Rx
Medical Devices·6 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Kopf Adapter S Sterile, Rx
Medical Devices·2,011 affected·Sep 4, 2012
High RiskFDA
James G. Cole, Inc.
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
Drugs·253 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Injectable Drugs·172,350 affected·Aug 28, 2012
High RiskFDA
Hospira Inc.
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC...
Injectable Drugs·26,100 affected·Aug 28, 2012
Medium RiskFDA
Viscot Medical Llc
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field du...
Surgical Devices·458,589 affected·Aug 22, 2012
CriticalFDA
Vycor Medical, Inc.
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System...
Surgical Devices·3,000 affected·Aug 21, 2012
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel &am...
Medical Devices·30 affected·Aug 21, 2012
High RiskFDA
Steris Corporation
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization pro...
Medical Devices·64 affected·Aug 10, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a pr...
Medical Devices·182 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a pr...
Medical Devices·270 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a pr...
Medical Devices·286 affected·Aug 9, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to trea...
Medical Devices·100 affected·Aug 6, 2012
High RiskFDA
Hospira, Inc.
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a c...
Medical Devices·0 affected·Aug 2, 2012
RecallFDA
Mallinckrodt Inc
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For ...
Injectable Drugs·12 affected·Jul 30, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 3...
Medical Implants·8 affected·Jul 27, 2012