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
Zimmer, Inc.
HGP II ACETABULAR CUP MOD
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP BON
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
6 DEGREE COCR FEM HEAD 36
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR ...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended ...
Respiratory Devices·780 affected·Oct 10, 2013
High RiskFDA
Zimmer, Inc.
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a tempo...
Medical Implants·94 affected·Oct 9, 2013
High RiskFDA
Medtronic Vascular, Inc.
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Gala...
Medical Implants·201 affected·Oct 7, 2013
High RiskFDA
Specialty Enzymes & Biotechnologies
Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113...
Food·5,780 affected·Oct 3, 2013
High RiskFDA
Specialty Enzymes & Biotechnologies
Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CEL...
Food·33,247 affected·Oct 3, 2013
High RiskFDA
Specialty Enzymes & Biotechnologies
Papain: NF 4-608 B NF 4-6152 NUTRA 6-452 PAPAIN PROHYDROXY NF 4-714
Food·625 affected·Oct 3, 2013
High RiskFDA
Specialty Enzymes & Biotechnologies
XYLANASE 150,000
Food·420 affected·Oct 3, 2013
High RiskFDA
Specialty Enzymes & Biotechnologies
Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14...
Food·13,685 affected·Oct 3, 2013
RecallFDA
Advanced Sterilization Products
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13...
Surgical Devices·267 affected·Oct 3, 2013
High RiskFDA
Nephron Pharmaceuticals Corp.
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carto...
Oral Drugs·689,568 affected·Oct 2, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone ant...
Medical Implants·1 affected·Sep 30, 2013
High RiskFDA
Baxter Healthcare Corp.
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is recons...
Medical Devices·38,400 affected·Sep 25, 2013
High RiskFDA
Hospira Inc.
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 04...
Injectable Drugs·681,400 affected·Sep 24, 2013
High RiskFDA
Hospira Inc.
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 040...
Injectable Drugs·251,400 affected·Sep 24, 2013
High RiskFDA
Ebi, Llc
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal...
Medical Devices·2 affected·Sep 24, 2013
CriticalFDA
Baylis Medical Corp *
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sh...
Cardiac Devices·370 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless othe...
Medical Devices·830 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless ...
Medical Devices·222 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless other...
Medical Devices·3,980 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised...
Medical Devices·200 affected·Sep 23, 2013
High RiskFDA
Richard Wolf Medical Instruments Corp.
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: on...
Medical Devices·78 affected·Sep 18, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and mo...
Medical Devices·2,995 affected·Sep 18, 2013
High RiskFDA
Hospira, Inc.
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactu...
Injectable Drugs·29,700 affected·Sep 16, 2013
High RiskFDA
Medtronic Vascular, Inc.
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtroni...
Surgical Devices·122 affected·Sep 16, 2013
High RiskFDA
Amerisource Bergen
Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed b...
Injectable Drugs·60 affected·Sep 13, 2013
High RiskFDA
Amerisource Bergen
Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed b...
Injectable Drugs·49 affected·Sep 13, 2013
High RiskFDA
Janssen Pharmaceuticals, Inc.
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458...
Drugs·70,495 affected·Sep 11, 2013
High RiskFDA
Integra Limited
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G,...
Respiratory Devices·79,887 affected·Sep 10, 2013
RecallFDA
Pack Pharmaceuticals, Llc
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene...
Ophthalmic Drugs·2,022 affected·Sep 9, 2013
Medium RiskFDA
Pack Pharmaceuticals, Llc
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene...
Ophthalmic Drugs·122,551 affected·Sep 9, 2013
High RiskFDA
Avella Of Deer Valley, Inc.
Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
Drugs·250 affected·Sep 9, 2013
RecallFDA
Pack Pharmaceuticals, Llc
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethyle...
Ophthalmic Drugs·78 affected·Sep 9, 2013
High RiskFDA
Avella Of Deer Valley, Inc.
Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684
Drugs·750 affected·Sep 9, 2013
RecallFDA
Pack Pharmaceuticals, Llc
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene...
Ophthalmic Drugs·3,415 affected·Sep 9, 2013
High RiskFDA
Becton Dickinson & Co.
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: ...
Medical Devices·187,000 affected·Sep 9, 2013
High RiskFDA
University Compounding Pharmacy
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Injectable Drugs·70 affected·Sep 6, 2013
High RiskFDA
University Compounding Pharmacy
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Injectable Drugs·178 affected·Sep 6, 2013
High RiskFDA
Apothecary Shoppe
SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
Injectable Drugs·1,430 affected·Sep 6, 2013
CriticalFDA
Altaire Pharmaceuticals, Inc.
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand L...
Ophthalmic Drugs·363,746 affected·Sep 6, 2013
High RiskFDA
University Compounding Pharmacy
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
Injectable Drugs·85 affected·Sep 6, 2013
High RiskFDA
University Compounding Pharmacy
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.
Injectable Drugs·37 affected·Sep 6, 2013