fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

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
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalled 5 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Warning (2025)

Sedecal SA recalled 5 SM-40HF-B-D-C 40KW 55G Mobile X-ray systems distributed in the US (CA, IL, NJ) after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines the possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and contact Sedecal SA for instructions.

Sedecal SA
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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
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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
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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
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal Mobile X-ray System Recall: 3 Units Not Water-Resistant (2025)

Sedecal SA recalled 3 units of the SM_40HF_B_D_VIR3.004 Mobile X-ray system distributed to consignees in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned strictly per the manual. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Sedecal
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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
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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
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 3-Unit Mobile X-ray System 40KWFXPLUS.004 Over Cleaning and Water-Resistance Conc

Sedecal SA recalled 3 units of the Mobile X-ray system 40KWFXPLUS.004 distributed in California, Illinois and New Jersey after warning users the device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could have consequences. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.

Sedecal
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalled 1 Mobile X-ray System 40KWFXPLUS.889 in 2025 for Cleaning Not Water-Resistant

Sedecal SA recalled 1 unit of the Mobile X-ray System 40KWFXPLUS.889 distributed in California, Illinois and New Jersey. The recall concerns cleaning practices and the device not being water-resistant. Hospitals and clinics should stop using the device immediately and follow recall instructions. Contact Sedecal SA for instructions via the recall notice distributed by email.

Sedecal SA
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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
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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
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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 40KWFXPLUS Mobile X-ray System Recall 268 Units in 2025

SEDECAL SA recalled 268 units of the 40KWFXPLUS Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual. Healthcare facilities should stop using the device immediately and await further recall instructions.

SEDECAL SA
Sedecal sent
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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 Recalled 5 SM-40HF-B-D-C Mobile X-ray Systems Over Cleaning Risk (2025)

Sedecal SA recalled 5 SM-40HF-B-D-C Mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees via email. The notice says the equipment is not water-resistant and must be cleaned strictly per the manual. Hospitals and clinics 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 SA 40KWFXPLUS.002 Mobile X-ray System Recalled in 2025 (8 Units)

Sedecal SA recalled 8 mobile X-ray units in the United States after notifying consignees that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice warns that improper cleaning could have consequences described in the manual. Healthcare providers and patients should stop using the devices immediately and contact Sedecal SA or their healthcare provider for the

Sedecal
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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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Tag Statistics

Total Recalls
1,264

Related Tags

electrical hazardchemical hazardinfant productadult productelderly producttip over riskfire hazardburn riskstop use immediatelyreturn for refundcpsc regulatedimmediate action