Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
Jun 10, 2025 SM_40HF_BDC3, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 SM_40HF_B_D_VIR3, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... Class II Boston Scientific Corporation
Jun 10, 2025 Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 Model Number 40KWFXPLUS.004, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 10, 2025 BostonSight PROSE Lens. Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. Class II Boston Foundation For Sight
Jun 10, 2025 BostonSight SCLERAL Lens Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. Class II Boston Foundation For Sight
Jun 10, 2025 MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... Class II SEDECAL SA
Jun 6, 2025 Akreos, SKU: AO60P0300. Akreos intraocular lenses An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 ... Class III Bausch & Lomb Surgical, Inc.
Jun 6, 2025 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101... As a result of a comprehensive product performance review it was determine that the device and in... Class II Boston Scientific Neuromodulation Corporation
Jun 5, 2025 Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05... High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Jun 5, 2025 High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Jun 5, 2025 Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Jun 5, 2025 Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K... High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Jun 5, 2025 Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog... Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... Class II Waismed Ltd.
Jun 5, 2025 Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog ... Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... Class II Waismed Ltd.
Jun 4, 2025 ADVIA¿ 120/2120/2120i SETpoint Calibrator Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 UROSKOP Omnia. Model Number: 10094910 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Numbe... An incoming complaint reported that the expiration date on the kit box label and Certificate of A... Class III DRG International, Inc.
Jun 4, 2025 Azurion 7 M20. Fluoroscopic X-Ray System. Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... Class II Siemens Healthcare Diagnostics, Inc.
Jun 4, 2025 UROSKOP Omnia Max. Model Number: 10762473 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2025 Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date... Class III Diversatek Healthcare
Jun 3, 2025 Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021Z... A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This... Class I Hamilton Medical AG
Jun 3, 2025 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr... Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
Jun 3, 2025 REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. ... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
Jun 3, 2025 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1... Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
Jun 3, 2025 Bravo CF capsule delivery device, designed to place and attach a pH monitorin... It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead ... Class I Given Imaging Ltd.
Jun 3, 2025 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
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.
Jun 3, 2025 REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cy... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... Class II Encore Medical, LP
Jun 2, 2025 Medshape Universal Joints, REF: DNE-9000-UJ Bone external fixation system may have the pin that can become dislodged resulting in frame insta... Class II Medshape, INC.
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... Class II Encore Medical, LP
May 30, 2025 Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Dr... Kit USB flash drive contains outdated software, which could result in reverting patient monitor t... Class II Remote Diagnostic Technologies Ltd.
May 30, 2025 Servo-u MR Ventilator System. Model Number: 6888800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 30, 2025 Hillrom LikoScale component, Product Code 3156232, used with the following a... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 30, 2025 Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Plate... Due to a risk of false positive results that could lead to unnecessary medical treatment. Class II Bio-Rad Laboratories, Inc.
May 30, 2025 Servo-n Ventilator System. Model Number: 6694800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Servo-u Ventilator System. Model Number: 6688600. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 29, 2025 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; ... Drug Elutable Microspheres have a smaller actual average diameter that is not within specificatio... Class II MICROVENTION INC.
May 29, 2025 Achieva XR Product Numbers: (1) 781153, (2) 781253; identified an issue where a component failure in the specific Gradient Coil type of affected syst... Class II Philips North America
May 29, 2025 Intera 1.5T Omni/Stellar; Product Number: 781104; identified an issue where a component failure in the specific Gradient Coil type of affected syst... Class II Philips North America
May 29, 2025 Intera 1.5T Master/Nova Product Number: 781106; identified an issue where a component failure in the specific Gradient Coil type of affected syst... Class II Philips North America

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.