Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
May 15, 2024 ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 HAND PACK-Procedure Kit Catalog Number: WEHD16B Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 15, 2024 TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded t... Class II American Contract Systems Inc
May 14, 2024 NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Cata... The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two ... Class II NxStage Medical Inc
May 14, 2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices. Devices were labelled with the incorrect guidewire labelling. Class II Applied Medical Technology Inc
May 14, 2024 VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow... The firm received reports that some blood collection tubes have experienced issues with clotting ... Class II Greiner Bio-One North America, Inc.
May 14, 2024 VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the V... Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration da... Class III Ortho-Clinical Diagnostics, Inc.
May 13, 2024 Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... Class II Roche Diabetes Care, Inc.
May 13, 2024 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 Class II Young Dental Manufacturing I, LLC
May 13, 2024 Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power... Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standa... Class II Draeger Medical Systems, Inc.
May 13, 2024 Aeos Robotic Digital Microscope, Product Code: PV010 Possibility of the robotic arm to drop more than 10cm from its original position after pressing t... Class II Aesculap Inc
May 13, 2024 Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and... One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contami... Class II SIGHT DIAGNOSTICS LTD
May 13, 2024 BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN ... Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... Class II CareFusion 303, Inc.
May 13, 2024 Non-sterile, single use, disposable gloves intended for medical purposes to b... Firm received complaints regarding skin irritation when using the gloves, disintegration of the g... Class II SVS LLC
May 13, 2024 BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH ME... Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... Class II CareFusion 303, Inc.
May 10, 2024 Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embeddi... An issue with safe usage of the device was identified whereby toxic smoke and internal fire devel... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
May 10, 2024 Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 878... Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of th... Class II Medtronic Neuromodulation
May 10, 2024 Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a compone... The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... Class II Beaver Visitec International, Inc.
May 10, 2024 MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227 The wrong configuration of the blade was in the package. The bevel was on the opposite side, inst... Class II Beaver Visitec International, Inc.
May 10, 2024 VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic E... Diagnostic electrophysiology (EP) catheters do not meet testing requirements. Class II Stryker Sustainability Solutions
May 10, 2024 IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a p... Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are ou... Class II Ion Beam Applications S.A.
May 10, 2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-... The terminal block used to secure the power supply cable for the gradient coil of the MRI system ... Class II Canon Medical System, USA, INC.
May 10, 2024 VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 9, 2024 First Source iQ Flex M. Portable cart and platform that supports an X-ray sys... Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... Class II First Source Inc
May 9, 2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard... Some of the devices may function incorrectly resulting in no temperature display or erratic tempe... Class II C.R. Bard Inc
May 9, 2024 Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is par... Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccur... Class II Echonous Inc
May 9, 2024 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... Class II Remote Diagnostic Technologies Ltd.
May 9, 2024 First Source Vision M. Portable cart and platform that supports an X-ray syst... Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... Class II First Source Inc
May 9, 2024 Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 1... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffman... The adjustment ring on the device may become loose resulting in the wire tension not being able t... Class II Stryker GmbH
May 9, 2024 Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syrin... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... Class I Thoratec Corp.
May 8, 2024 VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 120... Class III Ortho-Clinical Diagnostics, Inc.
May 8, 2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... Reports of patient burns. Class I Megadyne Medical Products, Inc.
May 8, 2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... Multitest with compromised raw material used to assess immune system status may result in flow cy... Class II Becton, Dickinson and Company, BD Biosciences
May 8, 2024 Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare en... There is a potential for the top cover of the hospital bed mattress to delaminate as a result of ... Class II Baxter Healthcare Corporation
May 7, 2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 ... Assays may produce false negative results due to decreased activity of the enzyme utilized in man... Class II Becton Dickinson & Co.
May 7, 2024 CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis ... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield

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.