fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Tuscan Artichoke and Mozzarella Salad Recalled for Undeclared Allergens (8.5 oz)

Fresh & Ready Foods recalled 233 units of Tuscan Artichoke and Mozzarella Salad distributed to 15 California locations after undeclared wheat and milk allergens were found. The allergen was not declared on the label. Consumers should not eat the product and should contact Fresh & Ready Foods LLC for refunds or replacements via email.

Fresh & Ready Foods
undeclared allergen
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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

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

Beckman Coulter UniCel DxH 690T Hematology Analyzer Recall Over HGB Photometer (2025)

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer REF C34520. The hematology analyzer may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. Labs 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 IQon Spectral CT 728332 Recalled Globally for Descending Patient Table Hazard

Philips North America has issued a recall for 81 IQon Spectral CT systems, Model 728332, sold worldwide. The patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer recall instructions.

Philips North America
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT Systems Recalled for Descent Hazard In 210-Unit Worldwide Distribution (2025)

Philips North America recalls 210 CT systems worldwide after reports that the patient support couch may descend unexpectedly to the lowest position following a replacement. Philips issued a recall dated 2025-08-13 with active status. The recall number is Z-2598-2025. Stop using immediately and follow manufacturer instructions.

Philips North America
The patient
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Health & Personal Care
HIGH
FDA DRUG

Novartis/Sandoz Otic Suspension Recalled for Temperature Abuse (D-0626-2025)

Novartis Manufacturing NV and Sandoz Inc recall ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension after temperature abuse. The recall affects one consignee in California. Consumers and health care providers should stop using the product immediately and follow guidance from Sandoz or a healthcare provider.

CIPROFLOXACIN AND DEXAMETHASONE
Temperature Abuse
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 800 Hematology Analyzers Recalled for High Hemoglobin Readings in High-WB

Beckman Coulter recalled the UniCel DxH 800 COULTER Cellular Analysis System configured with the Led HGB photometer. The recall affects models B24802, 629029, and B63322 and related configurations. A design-linked issue can yield erroneously high hemoglobin results when samples have elevated white blood cell counts. Stop using the device and follow the manufacturer’s recall instructions. Contact a

Beckman Coulter
Hematology analyzers
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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

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 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

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 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 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

kitchenimmediate actionstop use immediatelyreturn for refundcpsc regulatedburn riskchoking hazardpoisoning risklaceration risksuffocation riskexplosion riskreplacement available
    fda regulated Recalls | RecallRadar