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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

4,606 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,606 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 4,606 FDA device recalls in CA.

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DateProductReasonClassFirm
Oct 28, 2011 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, Mob... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 28, 2011 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileAr... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 17, 2011 da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which co... Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to ... Class II Intuitive Surgical, Inc.
Oct 13, 2011 UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Nu... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage:... Promotional literature for use of the da Vinci system for thyroidectomy, which had not been appro... Class II Intuitive Surgical, Inc.
Oct 13, 2011 UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; D... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; ... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 11, 2011 Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for t... A recall was initiated because Beckman Coulter has identified a negative bias in test results whe... Class III Beckman Coulter Inc.
Sep 23, 2011 UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usag... The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Sep 23, 2011 Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable T... Clarification of existing labeling and related cautions for the tip cover accessory of the da Vin... Class II Intuitive Surgical, Inc.
Sep 23, 2011 Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The... The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Sep 19, 2011 Cannula 8MM Regular. Provides the means of introduction and placement of a... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 Flush Port (used in almost all da Vinci instruments) Assists in cleaning t... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 da Vinci Si Surgeon Console. Intended to assist in the accurate Control of... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Aug 17, 2011 ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R... CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were ... Class II Codan Us Corporation
Aug 1, 2011 UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A6487... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Jul 27, 2011 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The... A recall communication was initiated because Beckman has identified that Access Total T4 calibrat... Class II Beckman Coulter Inc.
Jul 21, 2011 SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera... The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unif... Class II Discus Dental LLC
Jul 9, 2011 Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Pr... Please be aware that this is not a new recall. The firm has taken action; but, due to administrat... Class I First Medical Source LLC
Jul 6, 2011 ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.... The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in f... Class II Alphatec Spine, Inc.
May 31, 2011 Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment Syst... Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in ... Class II Varian Medical Systems, Inc. Oncology Systems
Dec 9, 2010 TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subse... The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw As... Class II Alphatec Spine, Inc.
Sep 22, 2010 ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600... Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because i... Class II Beckman Coulter Inc.
Aug 11, 2010 Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold th... This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli... Class II Breg Inc, An Orthofix Company
Jan 15, 2010 Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.01... Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit proper... Class II Medacta Usa Inc
Jan 6, 2010 ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.3... The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80... Class II Sendx Medical Inc
Nov 20, 2009 Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 20... The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to i... Class II CareFusion Corporation
Nov 17, 2009 CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for cathet... The recall was initiated because Biosense Webster has become aware of information regarding a pot... Class II Biosense Webster, Inc.
Jul 13, 2009 Whole Body X--ray Scanner This device is indicated as a whole body volume ... 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw dat... Class II Toshiba American Medical Systems Inc
Jun 1, 2009 Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
May 28, 2009 Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T... Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices becaus... Class II Alere San Diego, Inc.
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, 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.