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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.