fda regulated Recalls

1,319 recalls tagged with “fda regulated”.

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

Boston Scientific EndoVive PEG Kit Recalled for Sterility Risk in 806 Kits (2026)

Boston Scientific is recalling 806 EndoVive Safety PEG Kits sold nationwide. The recall concerns BD ChloraPrep Triple Swabsticks with open or compromised seals that could compromise sterility or dry the antiseptic solution. Hospitals and patients should stop using the kits immediately and follow the manufacturer's recall instructions.

Boston Scientific
Recall of
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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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Food & Beverages
HIGH
FDA FOOD

Hortex Mieszanka 9 Recall for Glass Contamination in 2026

1,134 units of Hortex Mieszanka 9 Spring Vegetable Mix are recalled in Illinois due to potential glass contamination. The recall involves LOT SoC1070925 and UPC 5900477018735. Consumers should stop using the product and contact Polski Ogrod Sp. z o.o. for refunds or replacements.

Polski Ogrod
potential contamination
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Health & Personal Care
HIGH
FDA DEVICE

Trividia Health TRUE METRIX PRO Owner's Booklet Recall for 1,001,534 Units (2026)

Trividia Health recalled 1,001,534 TRUE METRIX PRO owner’s booklets used with glucose meters distributed worldwide through multiple retailers. The labeling fails to clearly warn that an E-5 error could indicate very high blood glucose and does not emphasize immediate actions. Consumers should stop using the device and follow manufacturer recall instructions by letter, contacting Trividia Health or

Trividia Health
The system
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Health & Personal Care
HIGH
FDA DEVICE

International Life Sciences Recalls Artelon FLEXBAND TWIST Augmentation Devices for Endotoxin Test F

International Life Sciences issued an active recall of Artelon FLEXBAND TWIST augmentation devices. The devices were distributed worldwide, including nationwide in the United States. The recall concerns failures in bacterial endotoxin testing that could pose a infection risk; users should stop using the device and follow recall instructions from the manufacturer.

International Life Sciences
Augmentation devices
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Health & Personal Care
HIGH
FDA DEVICE

Trividia Health TRUE METRIX GO Recall for E-5 Error Misleading Labeling (1.4M, 2026)

Trividia Health's TRUE METRIX GO blood glucose kits sold at Walgreens, CVS and other retailers are recalled worldwide. The labeling fails to clearly emphasize that an E-5 error could indicate very high blood glucose and require immediate action. Consumers should stop using the device and follow manufacturer guidance.

Trividia Health
The system
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Health & Personal Care
HIGH
FDA DEVICE

Trividia Health Recalled 3.68 Million TRUE METRIX AIR Booklets for E-5 Error (2026)

Trividia Health recalled 3,678,026 TRUE METRIX AIR owner’s booklets distributed worldwide through Walgreens, CVS and other retailers. The recall centers on labeling for the E-5 error code, which could indicate very high blood glucose and lacks clear, immediate action guidance. Consumers should stop using the device and await manufacturer instructions mailed to customers.

Trividia Health
The system
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Health & Personal Care
HIGH
FDA DEVICE

International Life Sciences Recalls Artelon FlexBand Plus Augmentation Devices for Endotoxin Testing

International Life Sciences recalled Artelon FlexBand Plus augmentation devices after endotoxin testing failures. The recall affects devices with REF 41054 and REF 41057 distributed worldwide. Patients and healthcare providers must stop using the devices immediately and follow manufacturer instructions for recall return.

International Life Sciences
Augmentation devices
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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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Health & Personal Care
HIGH
FDA DRUG

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
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Tag Statistics

Total Recalls
1,319

Related Tags

immediate actionstop use immediatelyreturn for refundreplacement availablecpsc regulatedinfant productadult productelectronicbattery poweredlithium batteryvehiclenhtsa regulated