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