Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jun 10, 2025 Model Number SM-40HF-Batt; 40KW ANALOG, 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, 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 CANON READY.005, 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 EN, 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 50C, 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 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 SED URS LP, 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 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 Model Number SM-40HF-B-D-C; 40KW 70C READY, 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-710CW, 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 55C, 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 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 55C, 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 Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray s... 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-710CW.007, 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 VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VX... 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 SM-40HF-B-D-C; 40KW - CANON READY, 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 40KW-FX.899, 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 VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect i... 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 VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J... 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.005, 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.002, 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_VIR3.004, 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 SHIMADZU RF.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 40KWFXPLUS.889, 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 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 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 Model Number SM-20HF-Batt; 20KW ANALOG, 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.005, 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 40KWMOBILE3.899, 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 55C, 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 Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) 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 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 RADPRO MOBILE, 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_BDC, 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 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 Model Number SM-40HF-B-D-C; 40KW 80C, 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 55G/60G, 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 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 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 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 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 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 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 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.

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.