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
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Surgical Devices·37,686 affected·Jul 7, 2015
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Injectable Drugs·314,600 affected·Jul 2, 2015
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-00...
Injectable Drugs·189,912 affected·Jul 2, 2015
High RiskFDA
Mrp, Llc Dba Amusa
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Medical Devices·551 affected·Jul 2, 2015
High RiskFDA
The Apothecary Shoppe Llc
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 1...
Ophthalmic Drugs·40 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
Injectable Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
Injectable Drugs·98 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Drugs·55 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Drugs·750 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
Drugs·75 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
Injectable Drugs·67 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
Injectable Drugs·2 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Injectable Drugs·70 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05
Injectable Drugs·23 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85
Drugs·10 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
Injectable Drugs·2 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-196...
Injectable Drugs·64 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
Injectable Drugs·113 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
Drugs·20 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Injectable Drugs·163 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Drugs·10 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
Drugs·10 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Injectable Drugs·0 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Drugs·34 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19
Injectable Drugs·25 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
Injectable Drugs·1,200 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18
Injectable Drugs·555 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39
Injectable Drugs·5 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22
Injectable Drugs·5 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
Injectable Drugs·378 affected·Jun 26, 2015
High RiskFDA
The Apothecary Shoppe Llc
SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10
Drugs·32 affected·Jun 26, 2015
High RiskFDA
Alere Scarborough, Inc. Dba Binax, Inc.
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Inst...
Respiratory Devices·257 affected·Jun 26, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Medical Devices·16,992 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar he...
Medical Implants·16,992 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following u...
Medical Devices·16,992 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Medical Implants·16,992 affected·Jun 24, 2015
RecallFDA
Becton Dickinson & Company
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, ...
Medical Devices·238 affected·Jun 23, 2015
High RiskFDA
Argon Medical Devices, Inc
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBM...
Medical Devices·10,290 affected·Jun 18, 2015
High RiskFDA
Allergan Inc
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implan...
Medical Implants·167 affected·Jun 18, 2015
High RiskFDA
Symmetry Surgical, Inc.
SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws for...
Surgical Devices·2,708 affected·Jun 16, 2015
High RiskFDA
Liberty Drug & Surgical
Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main ...
Drugs·3 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham...
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·5 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·2 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatha...
Injectable Drugs·15 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Injectable Drugs·6 affected·Jun 15, 2015
High RiskFDA
Liberty Drug & Surgical
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195...
Injectable Drugs·6 affected·Jun 15, 2015