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Sedecal SA recalls

The FDA has posted 46 enforcement recalls from Sedecal SA since 2025, none of them Class I (most serious). Most recent report: Oct 29, 2025.

Class II: 46
Class IIOngoingZ-0254-2026

SEDECAL SA recalls Model Number SM-20HF-Batt

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0278-2026

SEDECAL SA recalls Model Number SM-40HF-B-D-C

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0277-2026

SEDECAL SA recalls Model Number SM-40HF-B-D-C

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0287-2026

SEDECAL SA recalls SM_40HF_BDC3

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0245-2026

SEDECAL SA recalls Model Number 40KW-FX.899

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0270-2026

SEDECAL SA recalls Model Number SM-40HF-B-D-C

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0283-2026

SEDECAL SA recalls SHIMADZU RF.004

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0255-2026

SEDECAL SA recalls Model Number SM-32HF-B-D-C

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0271-2026

SEDECAL SA recalls Model Number SM-40HF-B-D-C

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0243-2026

SEDECAL SA recalls MobileDiagnost wDR 2.2

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0248-2026

SEDECAL SA recalls Model Number 40KWFXPLUS.004

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025
Class IIOngoingZ-0284-2026

SEDECAL SA recalls SM_40HF_B_D_VIR3

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…

  • Mobile X-Ray System
  • Device Design
SEDECAL SAOct 29, 2025

Firm name as filed with the FDA: “SEDECAL SA”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.