Browse Device Recalls

71 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 71 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 71 FDA device recalls.

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DateProductReasonClassFirm
Oct 6, 2025 Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Oct 6, 2025 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Feb 15, 2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... Class II Abbott Medical
Nov 21, 2024 The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... Class II Abbott Medical
Oct 17, 2024 Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NV... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 1, 2024 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Oct 1, 2024 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Deep brain stimulation system will first turn off after approximately 50 days after the system is... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
Feb 5, 2024 Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Their is a potential that electromagnetic interference may cause leadless pacemaker may result in... Class II Abbott Medical
Aug 16, 2023 Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... Class II Abbott Medical
Aug 16, 2023 Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... Class II Abbott Medical
Jul 18, 2023 Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Dec 9, 2019 Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 40... Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths ins... Class II Abbott Medical
Dec 9, 2019 Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of ... Class II Abbott Medical
Nov 11, 2019 CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm... Class II Abbott Medical
Oct 14, 2019 Radiofrequency Grounding Pad, REF RF-DGP-L Affected lots were manufactured with the protective release liner in an incorrect orientation. W... Class II Abbott Medical
Sep 24, 2018 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... Class II Johnson & Johnson Surgical Vision Inc
Apr 1, 2017 Healon V, Part No. 10290045 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ... Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon 5 Pro, Part No. 10270015 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon Pro, Part No. 10270012 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Apr 1, 2017 Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 Remote possibility that certain solutions in these lots may contain microscopic glass particles d... Class II Abbott Medical Optics Inc. (AMO)
Mar 30, 2017 AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... Class II Abbott Medical Optics Inc. (AMO)

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.