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
Nov 1, 2024 Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... Class I Medtronic Neurosurgery
Nov 1, 2024 Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA ins... The DNA fragments for this specific lot number are too large, resulting in potential background a... Class II Kreatech Biotechnology Bv
Nov 1, 2024 FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... On October 18, 2024, BD has identified through customer complaints and an increase in field failu... Class II Becton, Dickinson and Company, BD Bio Sciences
Nov 1, 2024 Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Nov 1, 2024 Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Nov 1, 2024 Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... Class I Medtronic Neurosurgery
Nov 1, 2024 Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjuncti... Certain software versions will not notify end users of calls initiated by call points with the Ar... Class II Securitas Healthcare LLC
Oct 31, 2024 Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, ste... Specific lots of product have been manufactured with nonconforming raw materials resulting in the... Class II Wilson-Cook Medical Inc.
Oct 31, 2024 BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catal... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD EpiCenter Data Management System Version or Model: 440887 Catalog Number... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endo... Class II Olympus Corporation of the Americas
Oct 31, 2024 BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD EpiCenter Data Management System, Multi User Software Version or Model: 4... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Rec... Due a potential software/configuration issue that may result is incorrect alignment during recons... Class II Hermes Medical Solutions AB
Oct 31, 2024 BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: ... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US... Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurr... Class II Cartiva, Inc
Oct 31, 2024 BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Num... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 4... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444... BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 31, 2024 BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 BD confirmed that product service credentials used by some BD technical support teams to access c... Class II Becton Dickinson & Co.
Oct 30, 2024 Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to ... Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld. Class II INCIPIO DEVICES
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 29, 2024 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the... Class II Smith & Nephew Inc.
Oct 29, 2024 EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5... Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary ha... Class II MicroPort Orthopedics Inc.
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 28, 2024 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... Class III Remote Diagnostic Technologies Ltd.
Oct 28, 2024 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 SIGNA Architect, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, R... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 Discovery MR750w 3.0T, whole body magnetic resonance scanner Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Gradient coils for certain MR systems (see affected product list in this letter), under specific ... Class II GE Medical Systems, LLC
Oct 28, 2024 Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of ... Bronchoscopic visualization system power supplies have defective semiconductor components that ma... Class II Noah Medical
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 28, 2024 AMS Artificial Urinary Sphincter Control Pump Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 25, 2024 ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Me... Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expir... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 25, 2024 Galaxy System (GAL-001) Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... Class II Noah Medical
Oct 25, 2024 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... Class II Noah Medical
Oct 24, 2024 GE Proteus XR/A radiographic system Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have no... Class II GE Healthcare (China) Co., Ltd.
Oct 23, 2024 URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation

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.