Health & Personal Care Recalls

1,814 product recalls found in this category. Browse through all safety alerts and stay informed.

High Activity Category

This category has a significant number of recalls. Please check regularly for updates.

Health & Personal Care
HIGH
FDA DEVICE

LeMaitre Vascular Artegraft AG1015 Recall for 1 Unit Over Packing Error (2025)

LeMaitre Vascular recalled 1 Artegraft AG1015 vascular graft distributed to Arkansas hospitals after a packaging size labeling error. The packaging error could lead to using the wrong size graft during surgery. Hospitals and patients should stop using the device and follow recall instructions. See the recall letter for instructions from LeMaitre Vascular or your healthcare provider.

LeMaitre Vascular
The device
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Health & Personal Care
HIGH
FDA DRUG

Aloe Up Sunscreen Lotion SPF 30 Recalled for Microbial Testing Failure in 2025 (11,386 Tubes)

Aloe Up recalled 11,386 tubes of Aloe Up Sport Performance Sunscreen Lotion SPF 30 sold nationwide in the United States. The recall cites cGMP deviations after the product failed total aerobic microbial count testing. Consumers should stop using the product and follow guidance from SV Labs Prescott Corporation or a healthcare provider.

Aloe Up
cGMP deviations:
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Health & Personal Care
HIGH
FDA DRUG

ENTECAVIR Entecavir 0.5 mg Tablets Recalled Nationwide Over Impurity (2025)

Ent ecavir 0.5 mg tablets, distributed nationwide in the United States by Zydus Pharmaceuticals USA Inc., are recalled, affecting 912 bottles. The recall is due to an out-of-specification organic impurity detected in a batch, Class II. Healthcare providers and patients should stop using the product immediately and contact Zydus Pharmaceuticals USA for guidance.

ENTECAVIR
Failed impurity/degradation
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Health & Personal Care
HIGH
FDA DRUG

Zydus Entacavir Recall 600 Bottles Over Impurity Degradation Issue (2025)

Zydus Lifesciences and Zydus Pharmaceuticals USA recall 600 bottles of Entacavir 1 mg tablets distributed nationwide in the United States. An out-of-specification organic impurity triggered the recall. Stop use immediately and contact a healthcare provider or Zydus for guidance.

Entacavir
Failed impurity/degradation
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Health & Personal Care
HIGH
FDA DEVICE

BD EpiCenter Recall: 2,050 Units Worldwide Over Unauthorized Access Risk

BD recalled 2,050 units of the EpiCenter Microbiology Data Management System due to unauthorized access to product service credentials. The defect could allow access to confidential data. Stop using affected devices and follow manufacturer guidance for updates or replacement.

Becton Dickinson &
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD Phoenix M50 Recall: 4,283 Systems Worldwide Over Access Risk (2025)

BD recalled 4,283 Phoenix M50 Automated Microbiology Systems worldwide after unauthorized access to product service credentials. The unauthorized actor could access affected products and data. Labs should stop using these devices and follow the recall instructions from BD; contact BD for remediation guidance.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 62 BD MAX System IVD Units Worldwide Over Credential Breach (2025)

BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD BACTEC Blood Culture System Recall 1,086 Units Worldwide Over Unauthorized Access Risk (2025)

BD recalled 1,086 BD BACTEC Blood Culture System units worldwide after unauthorized access to product service credentials. The breach could compromise confidentiality, integrity and availability of affected devices and data. Hospitals and healthcare providers should stop using the device immediately and follow BD’s recall instructions.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 38 Veritor Connect Software Units Over Credential Access Risk (2025)

BD recalled 38 Veritor Connect Software units distributed to healthcare providers worldwide. Unauthorized access to product service credentials could affect confidentiality, integrity or availability of the product and data. Stop using the software and follow the recall instructions provided by the manufacturer.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

BD Recalls 177 BACTEC Blood Culture System Units Over Unauthorized Access Risk (2025)

BD recalled 177 units of the BACTEC Blood Culture System worldwide after an unauthorized actor accessed product service credentials. The breach could allow unauthorized access to system configurations and data. Healthcare facilities should stop using the affected equipment and follow BD’s recall instructions.

BD
Product service
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 160 DxC 500i Modules and DxI 9000 Analyzers in 2025 Recall

Beckman Coulter recalls 160 DxC 500i Clinical Analyzer Modules and the DxI 9000 Access Immunoassay Analyzer worldwide after a software anomaly could misapply manual dilution factors. The defect affects samples already in progress using the same Sample ID. Stop using the devices immediately and follow the recall instructions. Beckman Coulter will provide instructions via the recall process.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DRUG

Ascend Laboratories Recall Atorvastatin Calcium 40 mg Tablets for Failed Dissolution Specifications

Ascend Laboratories recalled Atorvastatin Calcium Tablets USP 40 mg, 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), and 1,000-count (NDC 67877-513-10) nationwide in the United States. The batches failed dissolution specifications. Patients should stop using the medication and contact Ascend Laboratories, LLC or their healthcare provider for guidance.

Atorvastatin Calcium
Failed Dissolution
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Health & Personal Care
HIGH
FDA DRUG

ATORVASTATIN CALCIUM Tablets 10 mg Recall: 141,984 Bottles Nationwide (2025)

Ascend Laboratories, Parsippany, NJ is recalling 141,984 bottles of ATORVASTATIN CALCIUM Tablets USP, 10 mg, nationwide, manufactured by Alkem Laboratories, Ltd. in India. The issue is failed dissolution specifications, which could lead to improper dosing. Healthcare providers and patients should stop using the product and contact Ascend Laboratories for guidance.

ATORVASTATIN CALCIUM
Failed Dissolution
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Health & Personal Care
HIGH
FDA DEVICE

Kico Knee Innovation ARVIS Shoulder AI Planning Software Recalled for High-Risk Malalignment in 21-0

Kico Knee Innovation recalls 21 ARVIS Shoulder systems nationwide after reports that AI planning software may cause implant malalignment or reduced range of motion. The recall covers software version V2025.1.2 used with IN-27300 hardware. Healthcare providers and patients should stop using the device and follow manufacturer instructions.

Kico Knee Innovation
Complaint identified
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 571 DxI 9000 Immunoassay Analyzers and DxC 500i (2025)

Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers and DxC 500i Clinical Analyzers distributed worldwide. A software anomaly may prevent correct application of manual dilution factors for tests already in progress on the same Sample ID. Labs should stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DRUG

Ascend Laboratories Recalls Alkem Atorvastatin Calcium 20 mg Tablets for Dissolution Failures (3 NDC

Ascend Laboratories recalls Alkem Atorvastatin Calcium Tablets USP 20 mg for dissolution failures in 2025. Distributed by Ascend Laboratories, Parsippany, NJ, nationwide. The issue: dissolution specifications not met. Stop use immediately and follow recall instructions. Check your NDC numbers to identify affected lots.

Ascend Laboratories
Failed Dissolution
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Category Statistics

Total Recalls
1,814
Pages
91