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
Envoy Medical Corporation
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable M...
Medical Implants·4 affected·Jun 28, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an aut...
Medical Devices·151 affected·Jun 27, 2018
High RiskFDA
Genicon, Inc.
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use o...
Medical Devices·1,550 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is ...
Medical Devices·8 affected·Jun 27, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Phar...
Injectable Drugs·17,610 affected·Jun 25, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compou...
Injectable Drugs·19,040 affected·Jun 25, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453...
Injectable Drugs·191 affected·Jun 25, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure P...
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-wa...
Surgical Devices·92,150 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK;...
Medical Devices·372 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,133 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·2,461 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·34,627 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/...
Medical Devices·656 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way...
Surgical Devices·4,332 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB ...
Medical Devices·342 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1...
Medical Devices·824 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·250 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·5,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,350 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·11,488 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Fol...
Surgical Devices·330 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley C...
Surgical Devices·1,588 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·14,326 affected·Jun 21, 2018
High RiskFDA
Ossur Americas
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML...
Medical Devices·138 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,025 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,028 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·475 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·2,784 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·153 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·4,372 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·250 affected·Jun 21, 2018