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Vehicle Safety

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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Jul 6, 2020 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 u... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 1, 2020 REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClav... Incorrect filter assemblies in IV administration set. Class II ICU Medical, Inc.
Jun 22, 2020 CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi... CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if ... Class II GE Healthcare, LLC
Jun 10, 2020 ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:0088687... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
Jun 10, 2020 Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:008868741... One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... Class II Intuitive Surgical, Inc.
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 8, 2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. Class II Medtronic Sofamor Danek USA Inc
Jun 3, 2020 HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam fo... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam ... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam f... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 2, 2020 Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usag... Identified products may contain a damaged bushing within the delivery system, which could potenti... Class II Cook Inc.
May 22, 2020 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node... Class II Siemens Medical Solutions USA, Inc.
May 7, 2020 MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be us... If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum b... Class II Siemens Medical Solutions USA, Inc
Apr 27, 2020 Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A,... HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv... Class II Philips North America, LLC
Apr 22, 2020 PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only S... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 22, 2020 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERI... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 14, 2020 BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential sta... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorgan... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorga... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Mar 18, 2020 Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC ... Class II WELCH ALLYN, INC/MORTARA
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M00617527208... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M00667030... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006... An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Mar 9, 2020 Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 An increase in the rate of complaints for difficulty or inability to track over the guidewire, ma... Class II Boston Scientific
Feb 25, 2020 Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrate... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Tra... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 25, 2020 Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Tran... It has been determined that the manufacturing process may have left foreign material particulates... Class II Acutus Medical Inc
Feb 14, 2020 The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; ... Firm identified software issues which leads to the patient ID and patient information not being s... Class II ICU Medical, Inc.
Feb 12, 2020 Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR,... Boston Scientific released a new Software Update Application that was downloaded to four (4) dist... Class II Boston Scientific Corporation

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.