Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Dec 19, 2024 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... Class II Ortho-Clinical Diagnostics, INc.
Dec 19, 2024 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 REF 471049 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... Class II Ortho-Clinical Diagnostics, INc.
Dec 19, 2024 Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... Class II Ortho-Clinical Diagnostics, INc.
Dec 19, 2024 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 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: 27030KB, Pediatric Cysto-Urethroscope, NON STERI... Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... Class II Karl Storz Endoscopy
Dec 19, 2024 BD PCR Cartridges used with MAX System. Model Number: 437519 Potential for signal drift in specific lots of BD PCR Cartridges. Class II Becton Dickinson & Co.
Dec 19, 2024 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 8MM,LONG TIP FORCEPS,IS4000 REF 471048 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 470205 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: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... 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,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 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: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, 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, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... Class II Intuitive Surgical, Inc.
Dec 19, 2024 Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-... During the assembly of the cartridge to its connecting body part, the valve may open prematurely ... Class II New Medical Technologies Gmbh
Dec 19, 2024 KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE 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,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.

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.