Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Feb 21, 2024 MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 Thermalon Eye Compress, Item Number 2434 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 MediBeads Neck Wrap, Item Number 34320 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... Class II Puritan Medical Products Company, Llc
Feb 21, 2024 Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detec... Class II Covidien
Feb 21, 2024 Thermalon Neck Wrap, Item Number 24322 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Feb 21, 2024 Thermalon Sinus Compress, Item Number 24332 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 Thermalon Back Wrap, Item Number 24312 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 Thermalon Sinus Compress (French), Item Number 24332F Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 21, 2024 SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... Class II Alcon Research, LLC
Feb 21, 2024 Thermalon Stye Compress, Item Number 24352 Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... Class II Bruder Healthcare Company, LLC
Feb 20, 2024 EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition dir... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition d... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilit... Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Int... Class II Boston Scientific Corporation
Feb 20, 2024 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; ... Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top fil... Class II 3M Company - Health Care Business
Feb 20, 2024 Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A ... Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly op... Class II Terumo Cardiovascular Systems Corporation
Feb 20, 2024 EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutri... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nut... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 20, 2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... Class I Boston Scientific Corporation
Feb 20, 2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Product was mislabeled as a Surgical Cap at its dispenser level. Class III O&M HALYARD, INC.
Feb 20, 2024 EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutr... Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... Class II Boston Scientific Corporation
Feb 19, 2024 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Feb 19, 2024 Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42... Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the E... Class II ConvaTec, Inc
Feb 19, 2024 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Feb 17, 2024 Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... Class II Olympus Corporation of the Americas
Feb 17, 2024 Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... Class II Olympus Corporation of the Americas
Feb 16, 2024 Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... Low concentration of sodium pyruvate in the wash could compromise gamete development Class II CooperSurgical, Inc.
Feb 16, 2024 Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of s... Low concentration of sodium pyruvate in the wash could compromise gamete development Class II CooperSurgical, Inc.
Feb 16, 2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... There is a potential for sterile package breach. Class II Medtronic Inc.
Feb 16, 2024 Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of ... Low concentration of sodium pyruvate in the wash could compromise gamete development Class II CooperSurgical, Inc.
Feb 16, 2024 CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOT... Due to a manufacturing issue, device under process validation phase were inadvertently mixed into... Class II Biosense Webster, Inc.
Feb 16, 2024 Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or c... Class II Medivance Inc.
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 15, 2024 DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... Class II Philips North America Llc
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial ... Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperativ... Class II SEASPINE ORTHOPEDICS CORPORATION
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Their is a potential that Oximeter may automatically power off and on resulting in loss of monit... Class II Masimo Corporation
Feb 15, 2024 Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower ... Class II Bio-Rad Laboratories
Feb 14, 2024 STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer repo... Class II Baxter Healthcare Corporation
Feb 14, 2024 HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... Automated external defibrillators were shipped in their test configuration so there is a potentia... Class II HeartSine Technologies Ltd
Feb 14, 2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Randox Laboratories Ltd.
Feb 14, 2024 Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... Class II Covidien, LP
Feb 14, 2024 Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... Class II Covidien, LP
Feb 13, 2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver ... Class I DeRoyal Industries Inc
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Feb 12, 2024 Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument S... There is a galling effect (cold-weld) caused by friction between the array fixation pins and the ... Class II Think Surgical, Inc.

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.