All Product Recalls

Browse through 3,495 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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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HIGH
FDA DEVICE

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.

Beta Bionics
it was
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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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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

Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025

Siemens Medical Solutions USA is recalling 20 Artis Pheno image- intensifiied fluoroscopic X-ray systems distributed nationwide. The recall cites limited system movements after startup. Hospitals and healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.

Siemens Medical Solutions USA
Limited system
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