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
Sca Pharmaceuticals
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl D...
Injectable Drugs·370 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) S...
Injectable Drugs·40 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl D...
Injectable Drugs·118 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 10...
Injectable Drugs·80 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preser...
Injectable Drugs·70 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Contai...
Injectable Drugs·30 affected·May 18, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/1...
Injectable Drugs·100 affected·May 18, 2017
High RiskFDA
Baxter Healthcare Corporation
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporati...
Injectable Drugs·90,450 affected·May 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, De...
Injectable Drugs·113,590 affected·May 15, 2017
High RiskFDA
Arrow International Inc
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and ...
Medical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter pe...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous A...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Cook Inc.
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Medical Devices·4,369 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter perm...
Medical Implants·27,485 affected·May 9, 2017
High RiskFDA
Sterilmed Inc
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate num...
Surgical Devices·963 affected·May 8, 2017
High RiskFDA
Cook Inc.
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the...
Medical Devices·10,415 affected·May 3, 2017
High RiskFDA
Allergan Sales, Llc
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured b...
Topical Drugs·648 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabil...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stab...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32...
Medical Devices·24,969 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Medical Devices·445 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNI...
Medical Devices·1,707 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 14...
Medical Devices·510 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MM...
Medical Devices·27,279 affected·Apr 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32C...
Medical Devices·1,499 affected·Apr 28, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·3,331 affected·Apr 27, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·673 affected·Apr 27, 2017
High RiskFDA
Abbvie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Medical Devices·0 affected·Apr 27, 2017
High RiskFDA
Cook Inc.
Clarke-Reich Laparoscopic Knot Pusher
Medical Devices·178 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Stamey Needle
Medical Devices·698 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Endoscopic Introducer/Extractor
Medical Devices·46 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Pereyra-Raz Ligature Carrier
Medical Devices·257 affected·Apr 25, 2017
High RiskFDA
Bard Access Systems Inc.
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film ...
Surgical Devices·4,500 affected·Apr 25, 2017
High RiskFDA
Molnlycke Health Care, Inc
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Surgical Devices·956 affected·Apr 24, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Acumed Llc
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted...
Medical Implants·13,076 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
Medical Devices·2,251 affected·Apr 20, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.
Medical Devices·12,738 affected·Apr 20, 2017
High RiskFDA
Almore International Inc
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite In...
Medical Devices·1,773 affected·Apr 20, 2017
High RiskFDA
Qualgen
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneou...
Drugs·4,468 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Fo...
Drugs·4,883 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For...
Drugs·5,260 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For...
Drugs·1,666 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, S...
Drugs·6,361 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Fo...
Drugs·1,153 affected·Apr 19, 2017
High RiskFDA
Qualgen
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For S...
Drugs·4,815 affected·Apr 19, 2017