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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Philips C9-5EC Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 27, 2025 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product co... Class II Microbiologics Inc
May 27, 2025 O-arm O2 Imaging System. Mobile X-Ray System. A mechanical component that supports the O2 gantry to the support structure in affected devices m... Class II Medtronic Navigation, Inc.-Boxborough
May 23, 2025 Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a com... Class II Insulet Corporation
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Discovery MR750w 3.0T GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6... This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing ... Class II Steris Corporation
May 23, 2025 SIGNA PET/MR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-5... Investigation has identified that the age of the nylon packaging material has caused a loss of in... Class II CORIN MEDICAL, LTD.
May 23, 2025 SIGNA Architect GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a ... Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planni... Class II QUANTUM SURGICAL SAS
May 23, 2025 SIGNA Architect AIR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 Jewel Precision Reusable Rigid Sterilization Container System. Model Number: ... The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., mode... Class II Jewel Precision Sheet Metal & Machining Co, Inc.
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 22, 2025 Change Healthcare Cardiology Hemo Software Due to complaints, software update may cause software to unexpectedly shutdown. Class II CHANGE HEALTHCARE CANADA COMPANY
May 22, 2025 Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... Class II Stryker GmbH
May 22, 2025 Change Healthcare Cardiology Hemodynamics Software Due to complaints, software update may cause software to unexpectedly shutdown. Class II CHANGE HEALTHCARE CANADA COMPANY
May 22, 2025 Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... Class II Siemens Healthcare Diagnostics, Inc.
May 22, 2025 IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; Io... The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... Class II LTS Therapy Systems, LLC
May 22, 2025 IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; T... The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... Class II LTS Therapy Systems, LLC
May 22, 2025 Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog ... The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility she... Class II Jewel Precision Sheet Metal & Machining Co, Inc.
May 22, 2025 Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... Class II Stryker GmbH
May 21, 2025 REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 G... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood C... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for perfor... Due to demonstration units of chest compression system being provided to a customer which may pot... Class II Jolife AB
May 21, 2025 Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen C... Due to a software/firmware issue diabetes management system may provide a device error and cause ... Class II BIGFOOT BIOMEDICAL
May 21, 2025 REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 i... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x ... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 ... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a bu... Potential for shorter clotting times in clotting tests which have a dilution, leading to possible... Class II Diagnostica Stago, Inc.
May 21, 2025 REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 20, 2025 My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It... Required inspections were not performed on finished product prior to release and distribution. Class II Onkos Surgical, Inc.
May 20, 2025 ColoSense Test Kit, Part No. 80-001, component of ColoSense test Multiple plate failures documented as a result of the Low Positive Template Control being too hig... Class II Geneoscopy, Inc.
May 20, 2025 BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility te... BD has received additional complaints of intermittent false resistance results for PZA during sus... Class II Becton Dickinson & Co.
May 19, 2025 PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile There is the potential that the eccentrical adaptor with screw, black laser marking, use to ident... Class II Limacorporate S.p.A
May 19, 2025 Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - ... Product packaging contains the wrong part number and kit contents. Class II Neurovision Medical Products Inc
May 19, 2025 PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile There is the potential that the eccentrical adaptor with screw, black laser marking, use to ident... Class II Limacorporate S.p.A
May 16, 2025 GE Healthcare Versana Ultrasound Systems, sold under the following names and ... GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... Class II GE Medical Systems China Co., Ltd.
May 16, 2025 Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number... XXX Class II Drs Vascular, Inc
May 16, 2025 GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, dia... GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... Class II GE Medical Systems China Co., Ltd.
May 16, 2025 Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis K... Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper ... Class II THERAKOS DEVELOPMENT LIMITED
May 15, 2025 ARTIS is a family of dedicated angiography systems developed for single and ... In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, 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.