Browse Device Recalls

395 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 395 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 395 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 30, 2023	Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th...	Abbott has received reports of an increase in reactive negative controls and false positive resul...	Class II	Abbott Molecular, Inc.
Oct 19, 2023	ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Sep 29, 2023	Alinity c Iron Reagent, Reference Number 08P3920	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm...	Class II	Sentinel CH SpA
Sep 29, 2023	IRON assay, Reference Numbers 6K95-41 and 6K95-30	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm...	Class II	Sentinel CH SpA
Sep 28, 2023	Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning gen...	Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out o...	Class II	Abbott
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
Jul 12, 2023	FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li...	If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'...	Class II	Abbott Diabetes Care, Inc.
Jun 12, 2023	Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a per...	There is an overall reported incidence rate of 0.77% related to observed or potential air embolis...	Class I	Abbott
May 30, 2023	Alinity ci-series System Control Module, REF: 03R70-01	There are potential performance issues found in the Alinity ci-series System software versions 3....	Class II	Abbott Laboratories
Apr 24, 2023	Alinity i Anti-TPO Reagent Kit, List Number 09P3521	Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower ...	Class III	Abbott Ireland Limited
Feb 13, 2023	FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 13, 2023	FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 13, 2023	FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 9, 2023	FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use...	If using affected glucose monitoring app on Android 13 Operating System, extended periods of sign...	Class II	Abbott Diabetes Care, Inc.
Dec 9, 2022	Alinity m System. The Alinity m System is designed to automate the steps...	The firm identified the following three potential issues which may have impacted ADUs installed o...	Class II	Abbott Molecular, Inc.
Nov 24, 2022	Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI...	Reaction vessels may contain a potential contaminant that could affect their optical performance.	Class III	Abbott Laboratories
Nov 22, 2022	Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090	Reports of an increase in reactive negative controls and false positive results with certain lots...	Class II	Abbott Molecular, Inc.
Nov 22, 2022	Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096	Reports of an increase in reactive negative controls and false positive results with certain lots...	Class II	Abbott Molecular, Inc.
Nov 11, 2022	Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U...	The instrument was found to be installed without plunger assemblies in the clamp bar for an Ampli...	Class II	Abbott Molecular, Inc.
Oct 12, 2022	Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use	Abbott has identified potential performance issues for the Alinity m System software version 1.6....	Class II	Abbott Molecular, Inc.
Sep 8, 2022	Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Aug 19, 2022	Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1...	Reports received of an increase of message code 9186 (internal control failed) when using the kit.	Class II	Abbott Molecular, Inc.
Jul 26, 2022	ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27	One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking age...	Class II	Abbott Laboratories
Jul 19, 2022	The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.	Incorrect optical calibration	Class II	Abbott Molecular, Inc.
Jun 17, 2022	Merlin.net model MN5000 Software	The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog...	Class II	St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022	Merlin 2 PCS MER37000 programmer Model MER3400 software	The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog...	Class II	St. Jude Medical, Cardiac Rhythm Management Div...
Jun 9, 2022	Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ...	When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Abl...	Class II	Abbott
Jun 9, 2022	REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2...	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera...	Class II	Abbott Laboratories
Jun 9, 2022	REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2...	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera...	Class II	Abbott Laboratories
Jun 9, 2022	REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2...	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera...	Class II	Abbott Laboratories
May 25, 2022	a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hC...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson C...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 28, 2022	FIRMap" Catheter, 60mm Basket	Incorrect product labeling.	Class II	Abbott
Mar 30, 2022	Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, ...	There is a potential that the proximal marker may separate from the imaging catheter	Class I	Abbott Vascular
Mar 24, 2022	Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur...	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ...	Class II	Abbott
Mar 24, 2022	Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Cur...	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the ...	Class II	Abbott
Mar 11, 2022	20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)	Due to an increase in complaint trend for leaks and intermittent/loose connections.	Class II	Abbott Vascular

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.