Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Sep 24, 2013	Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Steri...	Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off dur...	Class II	Ebi, Llc
Sep 24, 2013	SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc...	Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ...	Class II	Baxter Healthcare Corp.
Sep 24, 2013	S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. ...	Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegi...	Class II	Sorin Group Deutschland GmbH
Sep 24, 2013	UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel Dx...	Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 62...	Class II	Beckman Coulter Inc.
Sep 24, 2013	Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates tha...	Handles and heads may not be compatible.	Class II	SpineFrontier, Inc.
Sep 24, 2013	Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilir...	Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator ...	Class II	Siemens Healthcare Diagnostics
Sep 24, 2013	Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-8...	Handles and heads may not be compatible.	Class II	SpineFrontier, Inc.
Sep 23, 2013	ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo...	A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and...	Class II	Volcano Corp
Sep 23, 2013	Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthe...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Ane...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Ane...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 Th...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesth...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-2...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthe...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional An...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont...	Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ...	Class III	Alere San Diego, Inc.
Sep 23, 2013	Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure Sys...	A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and...	Class II	Volcano Corp
Sep 23, 2013	Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesth...	Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m...	Class II	Smiths Medical ASD, Inc.
Sep 23, 2013	Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st...	The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh...	Class I	Baylis Medical Corp *
Sep 23, 2013	ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental a...	Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue...	Class II	Ivoclar Vivadent, Inc.
Sep 23, 2013	Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure Syst...	A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and...	Class II	Volcano Corp
Sep 20, 2013	The Vantage Digital Panoramic System delivers high-value features standard on...	An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3....	Class II	Midmark Corp dba Progeny Inc
Sep 20, 2013	Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)	The trial insertion instrument may disassemble during use due to a potentially weak weld on then ...	Class II	Aesculap, Inc.
Sep 20, 2013	MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended f...	The root cause investigation showed that the under-volume hazard can occur when the unit has bee...	Class II	Medrad Inc dba Bayer R&I
Sep 20, 2013	Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa...	Product mix occurred prior to final package and labeling process.	Class II	Biomet Microfixation, LLC
Sep 20, 2013	Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use d...	MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D)....	Class II	Maquet Cardiovascular, LLC
Sep 19, 2013	AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH...	GE Healthcare has recently become aware of a potential safety issue due to the image orientation ...	Class II	GE Healthcare, LLC
Sep 19, 2013	Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos...	GE Healthcare has recently become aware of a potential safety issue due to air leakage associated...	Class I	GE Healthcare, LLC
Sep 19, 2013	IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Arch...	System downtime and/or slow performance may result if software in use is an old version of IMPAX ...	Class II	AGFA Corp.
Sep 19, 2013	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology ...	Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Te...	Class I	Atossa Genetics, Inc.
Sep 19, 2013	Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7	The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not comp...	Class II	Aesculap, Inc.
Sep 18, 2013	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Steril...	Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because i...	Class II	Advanced Sterilization Products
Sep 18, 2013	GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus...	GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires ...	Class II	GE Healthcare Beijing , Hangwei Medical Systems...
Sep 18, 2013	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperat...	Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRA...	Class II	Advanced Sterilization Products
Sep 18, 2013	Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS metho...	Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 18, 2013	Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; V...	Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporizat...	Class II	Richard Wolf Medical Instruments Corp.
Sep 17, 2013	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, R...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 17, 2013	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Stra...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 17, 2013	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 17, 2013	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps N...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 17, 2013	Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI ...	Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shi...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 17, 2013	DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, ...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 17, 2013	Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoya...	The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m...	Class II	DeRoyal Industries Inc
Sep 16, 2013	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PA...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM ...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health Inc.
Sep 16, 2013	Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS...	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where un...	Class II	Carestream Health 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.