fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units

Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

CareFusion 303 BD Alaris System with Guardrails Suite MX Recall Impacts 1,025,567 Units (2026)

CareFusion 303 recalled 1,025,567 units of the BD Alaris System with Guardrails Suite MX with Point of Care Unit worldwide. The recall concerns labeling that fails to indicate which TLS version must be enabled for secure hospital Wi-Fi communication. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. The recall was issued by the FDA and is being

CareFusion 303
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Blockers Recalled for Attenuation Degradation in 51 Units Worldwide (2026)

Burlington Medical recalled 51 Blocker devices sold worldwide after a recall notice. The devices may degrade attenuation over time, shortening their lifespan. Stop using the devices immediately and follow the manufacturer’s recall instructions. Contact Burlington Medical, LLC or your healthcare provider for guidance. Distribution is worldwide.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Half Aprons Recalled for Attenuation Degradation Risk (2026)

Burlington Medical recalled 402 Half Aprons sold worldwide after potential attenuation degradation. Attenuation material Xenolite 800 may degrade over time, reducing shielding lifespan. Patients and healthcare providers should stop using the aprons immediately and contact Burlington Medical for recall instructions.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Recalled 15,438 Radiation Attenuation Vests Over Degradation Risk (2026)

Burlington Medical recalled 15,438 attenuation vests distributed worldwide after potential attenuation degradation over time. The vests use Xenolite 800 attenuation material and were produced between January 16, 2025 and January 21, 2026. Healthcare providers and patients should stop using the vest immediately and follow recall instructions.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Waldemar Link Embrace Drill Tower Recall 74 Units in 2026

Waldemar Link GmbH & Co. KG recalls 74 Embrace Drill Tower devices distributed in 15 U.S. states. The recall notes mixed-up article numbers in the overview of the instruments. The surgical steps are correct. Stop using the device immediately and follow manufacturer instructions.

Waldemar Link GmbH & Co. KG
The surgical
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Health & Personal Care
HIGH
FDA DEVICE

Waldemar Link Embrace Shoulder Drill Tower Recalled After Mislabeling; 75 Units in 2026

Waldemar Link GmbH & Co. KG recalled 75 Embrace Shoulder Drill Tower devices distributed to U.S. hospitals after discovering mixed-up article numbers in the device overview. The surgical steps are correct, but the overview labeling is inaccurate. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions sent by email.

Waldemar Link GmbH & Co. KG
The surgical
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical BAT Coverage Recall 1,489 Units Worldwide in 2026

Burlington Medical recalled 1,489 BAT Coverage units worldwide on 2026-02-11 after a design-related issue was identified. The recall targets attenuation material used in the device. The defect could affect the lifespan of the shielding. Healthcare providers and patients should stop using the device and follow manufacturer instructions. The recall is active as of 2026-04-08.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Leg Wraps Recall: 103 Units Worldwide in 2026

Burlington Medical, LLC recalled 103 leg wrap devices distributed worldwide through multiple retailers. The recall cites attenuation degradation over time that could shorten the devices' lifespan. Healthcare providers and patients should stop using them immediately and follow the manufacturer's recall instructions.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Demi Half Aprons Recalled for Attenuation Degradation Risk (2026)

Burlington Medical recalled 29 Demi Half Aprons distributed worldwide after finding attenuation material may degrade over time. The degradation shortens the protective lifespan. Healthcare facilities should stop using the aprons immediately and follow the manufacturer’s recall instructions.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Thyroid Shield Recall 2026 Affects 41,962 Units Worldwide

Burlington Medical recalled 41,962 Thyroid Shield units worldwide after identifying attenuation degradation that could shorten the device’s lifespan. The attenuation material may degrade over time, reducing shielding effectiveness. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the manufacturer notice.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Medline Puracol Collagen Wound Dressings Recalled for Elevated Endotoxin Levels (2026)

Medline recalled 108,971 units of Puracol MSC8522 and Puracol Plus MSC8622EP collagen wound dressings nationwide in the United States, with distribution to Mexico and Panama. Elevated endotoxin levels were identified in affected lots. Stop using the dressings and follow recall instructions provided by Medline or your healthcare provider.

Medline Industries, LP
Elevated endotoxin
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Health & Personal Care
HIGH
FDA DEVICE

Orthalign Lantern Knee Drill Plate Recalled for Bone-Cut Risk (2026)

Orthalign recalled 7 drill plates used with its Lantern Knee System distributed nationwide, including Utah. The parts were manufactured out of specification and can cause a bone cut up to 0.008 inch (2.8448 mm). Healthcare providers were notified by letter and instructions to stop using the devices.

Orthalign
Drill plates
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Health & Personal Care
HIGH
FDA DEVICE

Orthalign Drill Plate Recall 2026 for 7 Units Over Bone-Cut Risk

Orthalign recalled 7 pegged drill plates used with the Lantern Knee System due to out-of-spec manufacturing that can cause bone cuts up to 2.8448 mm. The devices were distributed in Utah and across the United States. Healthcare providers and patients should stop using the device immediately and await recall instructions by letter.

Orthalign
Drill plates
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Health & Personal Care
HIGH
FDA DEVICE

Reflexion Medical Recalls 12 RefleXion X1 Radiotherapy Systems for Software Defect (2026)

Reflexion Medical recalled 12 RefleXion X1 Radiotherapy System RXM1000 units sold to hospitals and healthcare providers in the United States after a software defect could cause a 5mm or greater misalignment and underdose. The defect occurs during angular roll corrections followed by a repeat localization, and the roll corrections from the initial localization are not carried through to treatment.

Reflexion Medical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Hitachi Proton Beam Therapy Device Recalled for Software Issues

Hitachi Ltd. recalled one unit of its Proton Beam Therapy System on February 6, 2026 due to a software anomaly. The issue may result in positional discrepancies during patient treatment. The recall affects distribution in Texas and Washington D.C.

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Software anomaly
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Tag Statistics

Total Recalls
689

Related Tags

immediate actionstop use immediatelycpsc regulatedreplacement availablereturn for refundelectronicmetalrepair availableinfant productkitchennhtsa regulatedpoisoning risk