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
Biomet, Inc.
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·20 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·46 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 F...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 0059720...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Steri...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Steri...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in t...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, ND...
Injectable Drugs·676,872 affected·Jun 6, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization pro...
Medical Devices·2,447 affected·Jun 4, 2013
High RiskFDA
Baxa Corporation
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished s...
Medical Devices·753 affected·Jun 4, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Medical Devices·865 affected·Jun 4, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment,...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, cat...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump conn...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Abrams Royal Pharmacy
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, ...
Injectable Drugs·1,100 affected·May 31, 2013
High RiskFDA
Sandoz Incorporated
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sa...
Injectable Drugs·297,200 affected·May 30, 2013
High RiskFDA
Deroyal Industries Inc
GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Surgical Devices·87 affected·May 30, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·5 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Bi mix, compounded by Olympia Pharmacy, Orlando, FL
Drugs·4 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL
Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Gentamicin 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·2 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
Drugs·3 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·1 affected·May 29, 2013
High RiskFDA
Lowlite Investments, Inc. D/b/a Olympia Pharmacy
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
Injectable Drugs·3 affected·May 29, 2013