replacement available Recalls

1,215 recalls tagged with “replacement available”.

Health & Personal Care
HIGH
FDA DEVICE

Orthofix Pillar SA Ti Spinal Implant Recalled for Labeling Error (2025)

Orthofix U.S. recalled 3 Pillar SA Ti intervertebral body fusion devices nationwide in the United States after a labeling discrepancy. The 37 mm implant width is correct on the front label, but the outer side flap and inner label information box incorrectly state 33 mm. Healthcare providers and patients should stop using the device immediately and await manufacturer instructions.

Orthofix U.S.
A 37
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Health & Personal Care
HIGH
FDA DEVICE

Quidel Dipstick Strep A Tests Recalled for Potential False Positives (Z-2545-2025)

Quidel recalls 22,470 Rapid Strep A Dipstick tests sold worldwide, including multiple U.S. states. The dipstick test may yield false positive results. Health providers and patients should stop using the device immediately and follow recall instructions. Check with Quidel for refund or replacement options.

Quidel
Dipstick strep
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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 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 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 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 SM-40HF-B-D-C 40KW Mobile X-ray System Recalled for Cleaning Not Water-Resistant Hazard (202

Sedecal SA recalls 6 units of the SM-40HF-B-D-C 40KW 80C Mobile X-ray system after warning consignees that the device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to safety risks. Hospitals and clinics in California, Illinois and New Jersey should stop using the device and follow the manufacturer's recall instructions.

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 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 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
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 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
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL SA SM_40HF_BDC Mobile X-ray System Recall Expanded in 2025 (1 Unit)

Sedecal SA recalled 1 unit of the SM_40HF_BDC Mobile X-ray System distributed in California, Illinois and New Jersey after notifying consignees that the unit is not water-resistant and must be cleaned strictly per the manual. The notice cites potential consequences of improper cleaning. Hospitals and providers 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 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 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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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 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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Tag Statistics

Total Recalls
1,215

Related Tags

immediate actionstop use immediatelyreturn for refundfda regulatedcpsc regulatedglassmetalelectronicrepair availablechemical hazardelectrical hazardinfant product