fda regulated Recalls

1,320 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Sedecal Mobile X-ray System Recall for 1 Unit Over Water Exposure Cleaning Hazard (2025)

Sedecal SA recalls 1 unit of Model 40KWMOBILE3.899 Mobile X-ray system distributed to consignees in the United States, including California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual, with the notice outlining the potential consequences of improper cleaning. Healthcare providers and patients should stop using the device immediat

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 14 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Not Water-Resistant Risk (2025

Sedecal SA recalled 14 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees by email that the devices are not water-resistant. The company says cleaning must follow the manual strictly, warning about possible consequences of improper cleaning. Healthcare facilities and patients should stop using the devices immediately and follow the REMS

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 9 SM-40HF-Batt Mobile X-ray Systems (2025)

Sedecal SA is recalling 9 units of the SM-40HF-Batt 40KW analog Mobile X-ray System distributed in California, Illinois and New Jersey. The company sent an email to consignees warning the equipment is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause system damage. Hospitals and clinics should stop using the devices immediately and contact Sedecal SA or

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalled 6 Mobile X-ray Systems for Water-Resistance Cleaning Issue (2025)

Sedecal SA recalled 6 SM-40HF-B-D-C mobile X-ray systems distributed to consignees in California, Illinois and New Jersey after a notice reminded users the devices are not water-resistant and must be cleaned strictly per the manual. The reminder outlined possible consequences of improper cleaning. Hospitals should stop using the devices and follow the manufacturer’s recall instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal MobileDiagnost wDR 2.2 Recall for 1,198 Units in 2025

Sedecal recalled 1,198 MobileDiagnost wDR 2.2 mobile X-ray systems distributed in California, Illinois and New Jersey. The company reminded users the equipment is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could have consequences outlined by Sedecal. Health care providers should stop using the device immediately and follow recall instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SM-32HF-B-D-C 32KW Mobile X-ray System Recall Expanded (2025)

Sedecal SA recalled 8 SM-32HF-B-D-C 32KW 50G Mobile X-ray systems sold in the US and Canada after notifying consignees by email that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines possible consequences of improper cleaning. Hospitals should stop using the devices immediately and follow the recall instructions.

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal Mobile X-ray System Recall for Not Water-Resistant Design Affects 10 Units (2025)

Sedecal SA recalls 10 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey. The recall stems from a warning that the equipment is not water-resistant and must be cleaned strictly according to the manual. Hospitals and providers should stop using the device immediately and contact Sedecal for instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 4 SM-40HF-B-D-C Mobile X-ray Systems in 2025

Sedecal SA recalled 4 SM-40HF-B-D-C 40KW mobile X-ray systems sold in California, Illinois and New Jersey. A notice warns the equipment is not water-resistant and must be cleaned exactly as described in the manual to avoid possible consequences of improper cleaning. Healthcare providers should stop using the device immediately and contact Sedecal SA or their provider for instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls Shimadzu RF.004 Mobile X-ray System in 2025

Sedecal SA is recalling the Shimadzu RF.004 Mobile X-ray System after warnings that the device is not water-resistant and must be cleaned strictly according to the manual. Hospitals in California, Illinois, and New Jersey are affected. Stop using the device and follow recall instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal 40KWFX Mobile X-ray System Recall Affects 55 US Units (2025)

Sedecal recalled 55 Mobile X-ray System units sold to facilities in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned exactly as described in the manual, with clear warnings about the consequences of improper cleaning. Hospitals and healthcare providers should stop using the device immediately and follow Sedecal's recall instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recalled for Cleaning Water-Resistance Issue (2025)

Sedecal SA recalled 39 mobile X-ray systems due to a cleaning instruction issue that could cause improper maintenance. The recall affects units in the US and Canada. An email to consignees emphasizes the device is not water-resistant and must be cleaned per the manual, outlining potential consequences of improper cleaning. Healthcare facilities should stop using the device immediately and followSE

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 1 Unit 40KW-FX.899 Mobile X-ray System Over Cleaning Hazard (2025)

Sedecal SA recalled 1 unit of the 40KW-FX.899 Mobile X-ray System distributed to CA, IL and NJ. The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause adverse effects. Stop using the device and contact Sedecal SA or a healthcare provider for instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL SA Mobile X-ray System SM_40HF_BDC3 Recalled for Cleaning Risk (1 Unit, 2025)

SEDECAL SA recalled 1 unit of SM_40HF_BDC3 Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly per the manual. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal Recalled 7 Mobile X-ray Systems Over Cleaning Not Water-Resistant Issue (2025)

Sedecal recalled 7 mobile X-ray systems distributed to California, Illinois and New Jersey after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice highlights potential consequences of improper cleaning. Hospitals and clinicians should stop using the device and follow the manufacturer’s recall instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 1 SM-40HF-B-D-C Mobile X-ray System in 2025

Sedecal SA recalled 1 unit of SM-40HF-B-D-C 40KW 55C Mobile X-ray System distributed to CA, IL and NJ. The recall notice warns the device is not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Facilities and healthcare providers should stop using the device immediately and follow the recall instructions. Notification was sent by email.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recall 2025

Sedecal SA recalled 4 units of the SM-40HF-B-D-C 40KW Mobile X-ray System distributed to U.S. facilities in California, Illinois and New Jersey. The equipment is not water-resistant and must be cleaned strictly according to the manual. Facilities should stop using the device immediately and follow the manufacturer’s recall instructions.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recalled (2025)

Sedecal SA recalled a single SM-40HF-B-D-C 40KW mobile X-ray unit distributed to California, Illinois and New Jersey. The device is not water-resistant and must be cleaned per the manual, with explicit warnings about improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA SM-40HF-B-D-C Mobile X-ray System Recall for Cleaning Not Water-Resistant Risk (2025)

Sedecal SA recalled 1 mobile X-ray system in the United States. The device is distributed in CA, IL and NJ. The system is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have unspecified consequences. Clinicians and facilities should stop using the device and follow manufacturer instructions.

Sedecal
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA SM-40HF-B-D-C Mobile X-ray System Recalled for 27 Units in 2025

Sedecal SA recalled 27 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey after warning consignees the equipment is not water-resistant and must be cleaned per the manual. The notice outlines possible consequences of improper cleaning. Hospitals and providers should stop using the device immediately and follow recall instructions.

Sedecal SA
Sedecal sent
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Tag Statistics

Total Recalls
1,320

Related Tags

electrical hazardimmediate actionstop use immediatelyreturn for refundelectronicmetalplasticgaragecpsc regulatedreplacement availablechemical hazardrepair available
    fda regulated Recalls | RecallRadar