Browse Device Recalls
54 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 54 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 54 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 10, 2025 | Model Number 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 SM-32HF-Batt; 32KW 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 SM-40HF-B-D-C; 40KW70CDEMO.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 40KWFX, 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 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 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 | 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 SM-40HF-B-D-C; 40KW 55G, 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.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 | 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 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 | 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 | 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 | 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 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 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 | 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 | 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 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 |
| Jan 22, 2024 | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model... | Potential interference with the anti-fall system. | Class II | SEDECAL SA |
| Dec 13, 2023 | Sedecal X Optima URS digital mobile diagnostic x-ray system. A a station... | Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. | Class II | SEDECAL SA |
| May 23, 2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | There is a software login in issue that may prevent the user from logging in. | Class II | SEDECAL SA |
| Feb 6, 2023 | Phoenix mKDR, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | Class II | SEDECAL SA |
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.