FDA medical device recalls
Formal FDA enforcement reports for medical devices — implants, monitors, diagnostic tests, and hospital and home-use equipment.
2,600 recalls in the last 12 months, translated into plain English.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IISedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWMOBILE3.899, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS-710CW, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS.889, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS.005, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS.004, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS.002, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIModel Number 40KWFXPLUS, Mobile X-ray system
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- 2025-10-29SedecalClass IIFollow Sedecal X-ray cleaning instructions carefully
Sedecal notified users that the Model 40KW-FX.899 mobile X-ray system is not water-resistant and must be cleaned exactly according to the manual instructions. Improper cleaning could damage the equipment.
- 2025-10-29SedecalClass IIFollow Sedecal X-ray cleaning instructions carefully
Sedecal reminded users that its 40KWFX mobile X-ray systems are not water-resistant and must be cleaned strictly according to the manual instructions. Improper cleaning could damage the equipment. This notice affects 55 units distributed in California, Illinois, and New Jersey.
- 2025-10-29SedecalClass IIFollow cleaning instructions for Sedecal X-ray equipment
Sedecal is reminding users that the MobileDiagnost wDR 2.2 mobile X-ray system is not water-resistant. Improper cleaning can damage the equipment and may affect its safety and performance. Users must follow the cleaning instructions in the equipment manual.
- 2025-10-29SedecalClass IISedecal 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-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
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