Browse Device Recalls

2,479 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,479 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 2,479 FDA device recalls.

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DateProductReasonClassFirm
Aug 29, 2025 ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound minia... Production assembly error resulting in the potential for reversed articulation, where moving the ... Class II ImaCor Inc.
Aug 26, 2025 GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... Reports of vascular graft delamination, which may lead to reduced access flow; cannulation diffic... Class II W L Gore & Associates, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... Class II Exactech, Inc.
Aug 6, 2025 Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, cla... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and ... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... Class II SEASPINE ORTHOPEDICS CORPORATION
Aug 6, 2025 Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and f... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Aug 6, 2025 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... Class II ICU Medical Inc.
Jul 31, 2025 Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 28, 2025 PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... Class II VANTIVE US HEALTHCARE LLC
Jul 28, 2025 TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... Class II VANTIVE US HEALTHCARE LLC
Jul 25, 2025 Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Softwa... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 24, 2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... Class II THOR Photomedicine Ltd
Jul 22, 2025 Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitr... Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain p... Class II Trinity Biotech USA
Jul 14, 2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 11, 2025 Plum Duo Infusion System, List Number: 400020401 ICU Medical identified two sequences of programming events and alarm interactions that may cause ... Class I ICU Medical, Inc.
Jul 8, 2025 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... Resistance and difficulties could occur while closing the retaining clip locking mechanism, which... Class II Boston Scientific Neuromodulation Corporation
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 16, 2025 SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE01... SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due t... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 3, 2025 SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-... Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete ... Class II ICU Medical, Inc.
May 16, 2025 Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis K... Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper ... Class II THERAKOS DEVELOPMENT LIMITED
May 12, 2025 IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... Class I Fresenius Kabi USA, LLC
May 2, 2025 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... Firm has identified Drug Library Management defects in the software: 1) DLM software does not all... Class II ICU Medical, Inc.
Apr 22, 2025 ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400... Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 22, 2025 ICU Medical Plum Solos, Item number 400011001; infusion pump Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 17, 2025 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 7, 2025 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt... Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possi... Class II Philips North America Llc
Mar 13, 2025 HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau... Class I Thoratec LLC
Mar 5, 2025 stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.

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.