fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 600 Hematology Analyzer with HGB Photometer Recalled in 2025

Beckman Coulter recalled the UniCel DxH 600 COULTER Hematology Analyzer configured with an LED HGB Photometer, distributed to laboratories worldwide. The device may produce erroneously high hemoglobin results when WBC counts are elevated. Labs and healthcare providers should stop using the device immediately and follow Beckman Coulter's recall instructions.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT Systems Brilliance 40/64 Channel and Ingenuity Flex Recalled for Couch Descent Risk (2025

Philips North America LLC is recalling 181 CT systems worldwide, including Brilliance CT 40 Channel 728235, Brilliance CT 64 Channel 728231, and Ingenuity Flex 728317. The patient support couch may descend to the lowermost position after a replacement. Hospitals and imaging centers should stop using the devices immediately and await recall instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Brilliance CT Systems Recalled for Descent Hazard in 2025 (73 Units)

Philips recalled 73 Brilliance CT systems worldwide after determining a ball screw misalignment could cause the patient couch to descend to the lowermost position. The recall covers Brilliance 16 Power, 728240; Brilliance CT 16 Slice, 728246; and Brilliance CT 6 Slice, 728256. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions immediately.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Brilliance iCT SP CT Systems Recalled for Descending Couch Hazard in 14 Units Worldwide (202

Philips recalled 14 Brilliance iCT SP CT systems, model 728311, sold worldwide including the United States. The patient support couch may descend unexpectedly to the lowermost position because of ball screw misalignment after a replacement. Hospitals should stop using the device immediately and await manufacturer instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ingenuity CT System Recall 2025: 285 Units Worldwide

Philips recalled 285 Ingenuity CT systems worldwide, including 728321, 728323 and 728326 models. A ball screw misalignment after a replacement can cause the patient couch to descend to the lowermost position. Hospitals and clinics should stop using the devices and follow Philips recall instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ingenuity CT Brazil 728325 CT System Recalled for 3 Units in 2025

Philips recalled 3 Ingenuity CT Family Brazil systems, Model 728325, distributed worldwide, including the United States. A ball screw misalignment after a replacement may cause the patient support table to descend to the lowest position. Hospitals and clinicians should stop using the device and follow Philips recall instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT 6000 CT Scanner Recall 6-Unit for Table Descent Risk (2025)

Philips North America recalled 6 CT 6000 scanners, Model 728307, distributed worldwide including the United States. The patient support table may descend unexpectedly to the lowermost position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer instructions. Contact Philips for guidance and next steps.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Penner Pacific Bathing Spa Recalled for Missing UDI (158 Units)

Penner Patient Care recalled 158 Penner Pacific Bathing Spa devices distributed nationwide in the United States. The device does not bear a unique device identifier. Healthcare providers and patients should stop using the device immediately and follow the recall instructions mailed to affected parties.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Bathing Spa Devices Recall for Missing Unique Device Identifier (Z-1500-2026)

Penner Patient Care recalled 643 devices nationwide after the FDA flagged missing unique device identifiers. The recall affects a broad range of Penner Pacific Bathing Spa models. The device lacks a unique device identifier, posing regulatory and traceability concerns. Stop using the device and follow recall instructions from Penner Patient Care or a healthcare provider.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Bathing Spa Recalled for Missing UDI in 2025

Penner Patient Care recalled 45 Penner Pacific Bathing Spa units distributed nationwide in the United States. The devices do not bear a unique device identifier. Patients and healthcare providers should stop using this device immediately and follow the recall instructions provided by the manufacturer.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Change Healthcare Radiology Solutions Software Version 14.2.2 Recalled for Incomplete Reports

Change Healthcare recalled 12 programs of its Radiology Solutions software version 14.2.2 after reports surfaced that radiology reports may not display completely. This software flaw could lead to incomplete medical assessments and potential health risks. Healthcare providers and patients should stop using the software immediately and follow the recall instructions.

CHANGE HEALTHCARE CANADA
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care Recalls 26 Penner Pacific Bathing Spa Units for Missing UDI Label (2026)

Penner Patient Care recalled 26 Penner Pacific Bathing Spa units distributed nationwide in the United States after finding they do not bear a unique device identifier. The absence of a UDI prevents reliable traceability of the devices. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Penner Pacific Bathing Spa Recall: 10 Units Missing UDI (2025)

Penner Patient Care recalled 10 Penner Pacific Bathing Spa units nationwide on 2025-08-13 after regulators flagged the device lacks a unique device identifier. The device does not bear a unique device identifier. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care's Penner Pacific Bathing Spa Recalled for Missing UDI in 21 Units (2025)

Penner Patient Care, Inc. recalled 21 Penner Pacific Bathing Spa units distributed nationwide in the United States after discovering the devices do not bear a unique device identifier. The missing UDI hinders traceability for adverse events and recalls. Consumers should stop using the devices and contact Penner Patient Care for instructions.

Penner Patient Care
The device
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Tag Statistics

Total Recalls
1,264

Related Tags

electronicimmediate actionstop use immediatelyreturn for refundreplacement availableglassfall hazardtip over riskcpsc regulatedinfant productadult productchemical hazard
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