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
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Medical Devices·3,827 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Medical Devices·7,148 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
Medical Devices·24,574 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
Medical Devices·240 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Medical Devices·1,643 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Medical Devices·708 affected·Aug 6, 2013
High RiskFDA
Getinge Usa Inc
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured f...
Medical Devices·61,301,606,636 affected·Aug 2, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Card...
Medical Devices·15,817 affected·Jul 26, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to ...
Medical Devices·1,923 affected·Jul 25, 2013
High RiskFDA
Nestle Healthcare Nutrition
Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500)....
Medical Devices·37,310 affected·Jul 24, 2013
High RiskFDA
Gyrus Medical, Inc
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYO...
Surgical Devices·1,140 affected·Jul 24, 2013
High RiskFDA
Biomet 3i, Llc
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave pr...
Surgical Devices·170 affected·Jul 22, 2013
High RiskFDA
Biomet 3i, Llc
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Surgical Devices·21 affected·Jul 22, 2013
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Ca...
Medical Devices·12,239 affected·Jul 18, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxid...
Medical Devices·217 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Steri...
Medical Devices·13,223 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01...
Medical Devices·758 affected·Jul 17, 2013
High RiskFDA
Aesculap, Inc.
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Surgical Devices·217 affected·Jul 16, 2013
High RiskFDA
Zimmer, Inc.
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bon...
Medical Implants·1,710 affected·Jul 16, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·81 affected·Jul 15, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·9 affected·Jul 15, 2013
High RiskFDA
Atrium Medical Corporation
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascu...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vas...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypa...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular acc...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascul...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Custom Medical Specialties, Inc.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restrict...
Medical Devices·2,610 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro...
Diabetes Devices·506,925 affected·Jul 10, 2013
High RiskFDA
Koojoo Trading Company
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing d...
Medical Devices·7 affected·Jul 3, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY...
Medical Devices·12,546 affected·Jul 2, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for ...
Medical Devices·10,537 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek M...
Medical Devices·6,040 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care R...
Medical Devices·6,000 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Mi...
Medical Devices·2,102 affected·Jul 2, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valv...
Medical Implants·915 affected·Jun 28, 2013
High RiskFDA
Apotex Inc
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M...
Ophthalmic Drugs·50,982 affected·Jun 25, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are inten...
Surgical Devices·99 affected·Jun 19, 2013
High RiskFDA
Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item code...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Hospira Inc.
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NO...
Medical Devices·14,400 affected·Jun 18, 2013
High RiskFDA
Pioneer Surgical Technology, Inc.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for...
Medical Devices·9 affected·Jun 14, 2013
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Onl...
Drugs·23,000 affected·Jun 13, 2013