cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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 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 Recalled 6-Unit SM-40HF-B-D-C Mobile X-ray System for Cleaning Not Water-Resistant (2025)

Sedecal SA recalled 6 units of the SM-40HF-B-D-C 40KW Canon Ready Mobile X-ray System sold in California, Illinois and New Jersey. The company warned the equipment is not water-resistant and must be cleaned strictly per the manual to avoid possible consequences of improper cleaning. Users should stop using the device immediately and follow recall instructions provided by the manufacturer.

Sedecal
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 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 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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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 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 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 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 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 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 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
Sedecal sent
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Vehicles & Parts
HIGH
NHTSA

Mercedes-Benz GLE 450E 4MATIC Recall for Rearview Mirror Attachment (2025)

Mercedes-Benz USA is recalling certain 2024 GLE 350 4MATIC, 2025 GLE 450e 4MATIC, and additional models sold through its dealer network. The issue involves a multi-purpose camera and rearview mirror that may detach from the windshield. Dealers will replace the windshield and reinstall the camera and mirror at no charge.

Mercedes-Benz
A detached
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    cpsc regulated Recalls | RecallRadar