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