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
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
Dec 6, 2024 Portrait Core Services, a set of software services that enable the communicat... There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... Class II GE Medical Systems, LLC
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 5, 2024 LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... Error on the main label and the patient label. The labels indicate a size XXL, this is a standard... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 5, 2024 Dialyzer Optiflux 160NRe Potential for internal blood leaks due to cracked polyurethane Class II Fresenius Medical Care Holdings, Inc.
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 4, 2024 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... Incorrect catheter connector within the kit resulting in inability to provide a secure connection... Class II B. Braun Medical, Inc.
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... Due to an increase in complaint that the percutaneous reference pin would not fit into the patien... Class II Medtronic Navigation, 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.