Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,550 FDA device recalls in 2012.

Date	Product	Reason	Class	Firm
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg B...	Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2...	Class II	Stryker Medical Division of Stryker Corporation
Dec 18, 2012	ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali...	Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ...	Class II	Abbott Laboratories, Inc
Dec 18, 2012	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg ...	Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2...	Class II	Stryker Medical Division of Stryker Corporation
Dec 18, 2012	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Surgical microscope The device is used to improve the visibility of object...	The brake in the Z axis and/or brakes in the AB and C axes failed during installation.	Class II	Leica Microsystems (Schweiz) Ag
Dec 18, 2012	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci...	Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom...	Class II	Cardinal Health
Dec 18, 2012	Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t...	The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of...	Class I	Ad-Tech Medical Instrument Corporation
Dec 18, 2012	Surgical microscope The device is used to improve the visibility of object...	The brake in the Z axis and/or brakes in the AB and C axes failed during installation.	Class II	Leica Microsystems (Schweiz) Ag
Dec 17, 2012	Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infu...	Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on J...	Class III	Animas Corporation
Dec 17, 2012	Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F...	Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" ne...	Class II	Vygon Corporation
Dec 17, 2012	Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table S...	Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may mig...	Class II	Mizuho OSI
Dec 17, 2012	Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Meda...	The tip of the Quadra Trial Broach size 0, broke during a surgery.	Class II	Medacta Usa Inc
Dec 16, 2012	QuietCare-Networked product, Facility Server/model: QC101601; The QuietCa...	Care Innovations detected a software anomaly: During the engineering investigation into the cause...	Class II	Intel-GE Care Innovations LLC
Dec 14, 2012	Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm...	Some of the individual extension set packages were improperly sealed, compromising the sterility ...	Class II	Baxter Healthcare Corp.
Dec 13, 2012	Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "C...	Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the sutu...	Class II	Riverpoint Medical, LLC
Dec 13, 2012	Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catal...	In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the...	Class II	Becton Dickinson & Co.
Dec 13, 2012	Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70...	Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the...	Class II	Philips Healthcare Inc.
Dec 13, 2012	REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product ...	The affected product was packaged with the incorrect introducer needle. The kit label indicates ...	Class II	Medical Components, Inc dba MedComp
Dec 13, 2012	SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patien...	SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts af...	Class II	Sr Instruments Inc
Dec 13, 2012	Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number...	The displayed value for the invasive blood pressure measurement of the IACS was different than th...	Class II	Draeger Medical, Inc.
Dec 13, 2012	Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartri...	Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly co...	Class II	Ortho-Clinical Diagnostics
Dec 12, 2012	Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 2...	The length markings on the Lightspeed LSX files were wrong.	Class II	Ormco/Sybronendo
Dec 12, 2012	Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) an...	The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely dep...	Class II	Abbott Laboratories
Dec 11, 2012	GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performa...	During electrical recertification testing it was found that the Voltage Scaling Board was non-con...	Class II	AMS Innovative Center - San Jose
Dec 11, 2012	Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Lis...	Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-...	Class II	Toshiba American Medical Systems Inc
Dec 11, 2012	BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:*...	Cartridges are not sealing properly during PCR testing and may cause false results, indeterminate...	Class II	Becton Dickinson & Co.
Dec 10, 2012	Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning...	Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu...	Class II	Integra LifeSciences Corp.
Dec 10, 2012	Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein th...	The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.	Class II	Arjo, Inc. dba ArjoHuntleigh
Dec 10, 2012	BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in p...	Enrichment media intended to enhance the cultivation of various microorganisms may fail to suppo...	Class II	Becton Dickinson & Co.
Dec 10, 2012	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital...	Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 7, 2012	Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; ...	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break...	Class II	Hospira Inc.
Dec 7, 2012	Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045;...	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break...	Class II	Hospira Inc.
Dec 7, 2012	Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest,...	The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break...	Class II	Hospira Inc.
Dec 6, 2012	Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling...	Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been...	Class II	Hill-Rom, Inc.
Dec 6, 2012	Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit...	Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The c...	Class III	Siemens Healthcare Diagnostics, Inc.
Dec 5, 2012	Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product ...	Canon Inc. had received 17 claims from our foreign sales companies between October to November ...	Class II	Canon Inc.
Dec 5, 2012	Companion External Battery, Part Number: 293001-001 The Companion External...	Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver ...	Class II	SynCardia Systems Inc.
Dec 5, 2012	Spacelabs Smart Disclosure System, Model 92810, is an integrated component of...	Displaying or printing of an incorrect waveform for the time indicated in the printout or display...	Class II	Spacelabs Healthcare, Llc
Dec 5, 2012	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I...	B. Braun Medical Inc. is informing our customers of a field correction previously performed to ad...	Class II	B Braun Medical, Inc.
Dec 4, 2012	Abbott m2000sp Instrument; an automated fluid handling system for performing ...	An issue with the m2000sp Instrument software has been identified whereby, after a series of step...	Class II	Abbott Molecular
Dec 3, 2012	SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protect...	An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im...	Class II	DePuy Orthopaedics, Inc.
Dec 3, 2012	SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr...	An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im...	Class II	DePuy Orthopaedics, Inc.
Dec 3, 2012	SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr...	An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im...	Class II	DePuy Orthopaedics, Inc.
Dec 3, 2012	SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr...	An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im...	Class II	DePuy Orthopaedics, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.