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
Hartmann Usa, Inc
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debr...
Medical Devices·101,546,391 affected·May 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta duri...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, g...
Medical Devices·13,531 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gy...
Medical Devices·50,698 affected·May 9, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRA...
Medical Devices·24 affected·May 7, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, ...
Medical Devices·30 affected·May 7, 2012
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Drugs·98,084 affected·May 4, 2012
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira...
Injectable Drugs·2,933,936 affected·May 4, 2012
High RiskFDA
Hospira Inc.
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Injectable Drugs·267,288 affected·May 4, 2012
High RiskFDA
Hospira Inc.
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30)...
Injectable Drugs·216,396 affected·May 4, 2012
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 m...
Injectable Drugs·2,137,660 affected·May 4, 2012
High RiskFDA
Hospira Inc.
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
Injectable Drugs·14,706 affected·May 4, 2012
High RiskFDA
Hospira Inc.
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
Injectable Drugs·136,584 affected·May 4, 2012
High RiskFDA
Hospira Inc.
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Injectable Drugs·74,256 affected·May 4, 2012
High RiskFDA
Hospira Inc.
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
Drugs·40,988 affected·May 4, 2012
High RiskFDA
Apotex Inc.
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthal...
Topical Drugs·119,794 affected·Apr 30, 2012
High RiskFDA
Microaire Surgical Instruments, Llc
Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: ...
Medical Devices·15 affected·Apr 26, 2012
High RiskFDA
Stryker Spine
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW...
Medical Devices·40 affected·Apr 25, 2012
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators...
Drugs·576 affected·Apr 23, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tis...
Surgical Devices·9,533 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with i...
Surgical Devices·37 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combine...
Surgical Devices·4,117 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with ...
Surgical Devices·3,541 affected·Apr 20, 2012
High RiskFDA
Bracco Diagnostics Inc
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use,...
Injectable Drugs·4,870 affected·Apr 16, 2012
RecallFDA
St Jude Medical Inc
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Mi...
Cardiac Devices·26 affected·Mar 28, 2012
High RiskFDA
Biomet 3i, Llc
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC A...
Medical Implants·240 affected·Mar 23, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Huma...
Medical Devices·208 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Hu...
Medical Devices·160 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tis...
Medical Devices·25 affected·Mar 14, 2012
High RiskFDA
Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Medical Devices·2,457 affected·Mar 13, 2012
RecallFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD,...
Medical Devices·225 affected·Mar 5, 2012
High RiskFDA
Orthosensor
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.co...
Medical Devices·9 affected·Feb 4, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Dis...
Medical Devices·532 affected·Jan 26, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Ormco/sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Medical Devices·4,543 affected·Dec 12, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·70 affected·Dec 9, 2011
High RiskFDA
Carefusion 213, Llc
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 26...
Drugs·67,775 affected·Nov 8, 2011
High RiskFDA
Biomet 3i, Llc
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13**...
Medical Implants·219 affected·Nov 4, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·124 affected·Oct 28, 2011
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC T...
Medical Implants·70 affected·Oct 17, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ...
Medical Devices·3 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The...
Medical Devices·538 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Medical Devices·16 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ski...
Medical Devices·6 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in sk...
Medical Devices·7 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices·4 affected·Sep 30, 2011