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
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue defi...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficienc...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the r...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
C P Medical Inc.
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled...
Surgical Devices·4 affected·Apr 23, 2014
High RiskFDA
Smiths Medical Asd, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regul...
Cardiac Devices·2,120 affected·Apr 22, 2014
High RiskFDA
Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mu...
Diagnostic Devices·580 affected·Apr 17, 2014
High RiskFDA
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the s...
Surgical Devices·2,591 affected·Apr 16, 2014
High RiskFDA
Biomet, Inc.
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic inst...
Surgical Devices·100 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through so...
Medical Devices·102 affected·Apr 15, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Medical Devices·0 affected·Apr 14, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass proced...
Medical Devices·0 affected·Apr 14, 2014
CriticalFDA
Smiths Medical Asd, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the pati...
Medical Devices·100 affected·Apr 10, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharm...
Injectable Drugs·200 affected·Apr 9, 2014
High RiskFDA
Small Bone Innovations, Inc.
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticul...
Medical Devices·44 affected·Apr 7, 2014
CriticalFDA
Baxter Corporation Englewood
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition...
Medical Devices·2,034 affected·Apr 2, 2014
High RiskFDA
Neo Metrics, Inc.
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactur...
Diagnostic Devices·1,256 affected·Mar 31, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product U...
Medical Devices·21,675 affected·Mar 28, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation ...
Medical Devices·29,380 affected·Mar 25, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (18...
Medical Devices·42,292 affected·Mar 25, 2014
High RiskFDA
Hospira Inc.
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; s...
Medical Devices·167,574 affected·Mar 25, 2014
High RiskFDA
Teva Pharmaceuticals Usa
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuti...
Drugs·47,890 affected·Mar 21, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fl...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dra...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dra...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for cl...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction dr...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Aspen Surgical Products, Inc.
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml ...
Medical Devices·0 affected·Mar 20, 2014
High RiskFDA
Merit Medical Systems, Inc.
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Medical Devices·15 affected·Mar 13, 2014
High RiskFDA
Teleflex Medical
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Tele...
Surgical Devices·7,380 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek I...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex ...
Surgical Devices·32,271 affected·Mar 11, 2014