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