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
Medline Industries Inc
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 419...
Drugs·779 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Me...
Drugs·20,430 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·250 affected·Sep 21, 2017
High RiskFDA
Deserving Health International Corp
Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337....
Drugs·623 affected·Sep 20, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Medical Devices·643 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Medical Devices·953 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Medical Devices·920 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Medical Devices·306 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Medical Devices·665 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Medical Devices·895 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Medical Devices·311 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Medical Devices·333 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Medical Devices·411 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Medical Devices·575 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Medical Devices·656 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Medical Devices·520 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Medical Devices·547 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Medical Devices·678 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Medical Devices·640 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Medical Devices·733 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Medical Devices·527 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Medical Devices·198 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Medical Devices·386 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Medical Devices·573 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Medical Devices·109 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Medical Devices·114 affected·Sep 19, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from...
Medical Devices·46 affected·Sep 15, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured ...
Medical Devices·48 affected·Sep 15, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee S...
Medical Implants·10 affected·Sep 14, 2017
High RiskFDA
The Metrix Company
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Medical Devices·50 affected·Sep 13, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc...
Drugs·22,080 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·96,828 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·130,740 affected·Sep 5, 2017
CriticalFDA
Genentech, Inc.
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP...
Injectable Drugs·16,882 affected·Sep 5, 2017
High RiskFDA
Simple Diagnostics, Inc.
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC...
Drugs·150,250 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·29,232 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Medical Devices·106,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·11,508 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
Medical Devices·235,560 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·128,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Medical Devices·16,380 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
Medical Devices·102,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 15 ml Normal Saline ¿
Medical Devices·357,552 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 550 ml Sterile¿¿ ¿
Medical Devices·54,924 affected·Sep 5, 2017
High RiskFDA
Pfizer Inc.
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentec...
Injectable Drugs·18,725 affected·Sep 1, 2017
High RiskFDA
Aaren Scientific Inc.
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren...
Medical Devices·786 affected·Sep 1, 2017