Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Infrastructure

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

Clear
DateProductReasonClassFirm
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 Extended Tip Applicator 8CM, Box of 1. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
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 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 Extended Tip Applicator, 8CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
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 Extended Tip Applicator, 15 CM, Box of 5. Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... Class I Integra LifeSciences Corp. (NeuroSciences)
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 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: 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 Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which m... Class I Covidien
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: 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 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: 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: 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 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 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 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 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 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 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 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 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: Q-Stop Product Name: Suture Retention Device Model/Catalog Number... XXX Class II Drs Vascular, Inc
May 15, 2025 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... Cook Medical identified that catheters supplied in the affected device lots may experience tip se... Class I Cook Incorporated
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 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... The impacted tape was manufactured with incorrect information on the tape. Incorrect values are p... Class I SunMed Holdings, LLC
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
May 15, 2025 Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution Contact lens insertion solution may lack sterility. Class II Contamac Solutions, Inc.
May 15, 2025 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr... Class II MEDLINE INDUSTRIES, LP - Northfield
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 13, 2025 Product Name: Upgrade to MR 7700; Model Number: 782130; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc

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.