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Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Dec 19, 2024 8MM,PROGRASP FORCEPS,IS4000 REF 471093 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 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 471309 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: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm,... 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,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 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: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STER... Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... Class II Karl Storz Endoscopy
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 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 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 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 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 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 Monitoring Service Application (MSA). Software to process, analyze, display, ... Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and ... Class I Braemar Manufacturing, LLC
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 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 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 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 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 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 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 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 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 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 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number... Potential for inadvertent retention of biomaterial when the reprocessing procedure is not perform... Class I 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 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 Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
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 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 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 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 Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
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: 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 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: 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: Premium Dressing Change Kit with GuardiVa... 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 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 ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
Dec 12, 2024 Impella RP with SmartAssist; Product Number: 0046-0035; Optical Sensors have been damaged due to physical interaction between the inlet and another devic... Class I Abiomed, Inc.
Dec 12, 2024 VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
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 ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
Dec 12, 2024 ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL... A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
Dec 12, 2024 PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),... A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
Dec 12, 2024 VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... Class I Boston Scientific Corporation
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

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.