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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

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 19, 2024 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON ... Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... Class II Karl Storz Endoscopy
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. Class II Karl Storz Endoscopy
Dec 19, 2024 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 18, 2024 GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2)... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT;... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Control indicating lower than expected quality control (QC) results and in some instances QC reco... Class II Instrumentation Laboratory
Dec 18, 2024 Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Ind... The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. T... Class II Tornier S.A.S.
Dec 18, 2024 GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System,... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-7... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H24... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee T... 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which m... Class II Encore Medical, LP
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 c... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30... Potential for distal tip tearing of the Mechanical Lithotriptor V. Class II Olympus Corporation of the Americas
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 15, 2024 Calibrate CCX Interbody System for spinal fusion procedures: Implants: ... Complaints have been received regarding post-operative implant collapse. Class II Alphatec Spine, Inc.
Dec 13, 2024 Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reag... Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or... Class II Hologic, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 12, 2024 SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Ther... Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... Class II LivaNova USA, Inc.
Dec 12, 2024 SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburs... Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... Class II LivaNova USA, Inc.
Dec 12, 2024 EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 11, 2024 MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent... Class II MICROVENTION INC.
Dec 11, 2024 Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003... Spore test strip monitoring system, designed for routine monitoring of sterilization processes, m... Class II HF Acquisition Co LLC
Dec 10, 2024 Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... Class II ev3 Inc
Dec 10, 2024 EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 Knee insert package may contain an acetabular system, which may cause surgical delay to get a new... Class II Encore Medical, LP
Dec 10, 2024 Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic aci... False-positive MSI-H results generated by the Idylla MSI Test. Class II Biocartis Nv
Dec 6, 2024 Temporary Titanium Abutments Certain definitive dental implant restoration cases may have included a temporary titanium abutme... Class II DDS Lab

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.