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
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used...
Medical Devices3 affectedSep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices3 affectedSep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Sol...
Medical Devices15 affectedSep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in th...
Medical Devices75 affectedSep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Medical Devices5 affectedSep 30, 2011
High RiskFDA
Bausch & Lomb, Inc.
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, F...
Drugs59,777 affectedJul 6, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for ...
Surgical Devices30,064 affectedJul 1, 2011
High RiskFDA
Nephron Pharmaceuticals Corp.
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per cart...
Drugs56,028 affectedJun 22, 2011
High RiskFDA
Cordis Corporation
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688...
Surgical Devices1 affectedJan 31, 2011
High RiskFDA
Sterigear, Llc
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1...
Surgical Devices110,560 affectedJan 11, 2011
High RiskFDA
Mallinckrodt Inc
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that pro...
Medical Devices75 affectedFeb 1, 2010
High RiskFDA
Orthohelix Surgical Designs Inc
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxT...
Medical Devices47 affectedJan 29, 2010
High RiskFDA
Spiegelberg Gmbh & Co. Kg
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: ...
Medical Devices22 affectedDec 29, 2009
High RiskFDA
Biomet, Inc.
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer ...
Medical Implants1,050 affectedDec 12, 2006