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
Owen Mumford Usa, Inc.
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-st...
Diabetes Devices·225 affected·Dec 11, 2014
High RiskFDA
Zimmer, Inc.
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Pro...
Medical Implants·67,963 affected·Dec 11, 2014
High RiskFDA
Mentor Texas, Lp.
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Medical Implants·45 affected·Dec 11, 2014
High RiskFDA
Med Tec Inc
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable ...
Medical Devices·2 affected·Dec 11, 2014
CriticalFDA
Covidien
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offe...
Medical Devices·1,032 affected·Dec 10, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for...
Medical Devices·8,640 affected·Dec 8, 2014
CriticalFDA
Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System...
Diagnostic Devices·231,967 affected·Dec 5, 2014
High RiskFDA
Zimmer, Inc.
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable ...
Medical Implants·83 affected·Dec 4, 2014
High RiskFDA
Baxter Corporation Englewood
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. E...
Medical Devices·54,000 affected·Dec 4, 2014
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per...
Injectable Drugs·62,650 affected·Dec 3, 2014
CriticalFDA
Leonhard Lang Gmbh
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: ...
Cardiac Devices·1,080 affected·Dec 3, 2014
RecallFDA
Lacrimedics Inc
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, an...
Medical Devices·781 affected·Nov 26, 2014
High RiskFDA
Baxter Healthcare Corp.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Con...
Injectable Drugs·7,220 affected·Nov 25, 2014
High RiskFDA
Teleflex, Inc.
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Becton Dickinson & Co.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Medical Devices·92,710 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Left), Sterile
Medical Devices·6,991 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Tracheopart Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Ca...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Teleflex Medical
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal in...
Medical Devices·14,000 affected·Nov 12, 2014
High RiskFDA
Cure Medical Llc
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P...
Surgical Devices·192 affected·Nov 11, 2014
High RiskFDA
Baxter Healthcare Corp.
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product ...
Injectable Drugs·63,360 affected·Nov 10, 2014
High RiskFDA
Perry Drug Inc.
HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
Drugs·186 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
Drugs·5 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
Injectable Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park...
Drugs·8 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Drugs·2 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-790...
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
Drugs·17 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
Drugs·10 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (compris...
Respiratory Devices·2,506 affected·Nov 7, 2014
High RiskFDA
Abbott Medical Optics Inc (amo)
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging...
Surgical Devices·484,881 affected·Nov 6, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use dev...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Custom Healthcare Systems, Inc.
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Medical Devices·3 affected·Nov 5, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpo...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Pulsion Medical Inc
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usa...
Cardiac Devices·90 affected·Nov 4, 2014
High RiskFDA
Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purp...
Medical Devices·19,978 affected·Nov 4, 2014
High RiskFDA
Bard Access Systems
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Medical Devices·2,532 affected·Nov 3, 2014