Health & Personal Care Recalls

1,882 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

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 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 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 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

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

Cardinal Health 200 Salem Sump Gastroduodenal Tubes Recalled Worldwide for ARV Breakage

Cardinal Health 200, LLC recalled Salem Sump gastroduodenal tubes worldwide after reports of anti-reflux valve breakage. The ARV can fail under excessive force during use. Healthcare providers and patients should stop using the device immediately and follow the manufacturer instructions for recall communication.

Cardinal Health 200
Firm has
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems LOGIQ P9 R4.5 Ultrasound System Recalled for Inaccurate Liver Readings (37 Units)

GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.

GE Medical Systems
The Ultrasound-Guided
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Set Recalled for Lid-Position Defect in 2025

B Braun Medical recalls the PERIFIX FX Continuous Epidural Anesthesia Set and PERIFIX Tuohy Epidural Needle nationwide after a lid-position defect is identified. The issue involves the lid of the catheter connector being in the incorrect position. Healthcare providers are advised to stop using the device and follow the manufacturer’s recall instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for 0 Units in 2025

B Braun Medical recalled the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide. The recall centers on the lid of the catheter connector that may be in the incorrect position. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical Recall: 60-Unit Anesthesia Tray Recalled for Catheter Connector Lid Position Issue

B BRAUN MEDICAL INC recalls 60 units of SESK Combined Spinal and Epidural Tray nationwide. The recall targets products distributed to all 50 states. The defective lid on the catheter connector may be in the incorrect position, posing a high-risk device issue. Stop using immediately and follow company instructions for recall remedies.

B BRAUN MEDICAL
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid Misalignment in 48,110 Units (2025)

B Braun Medical Inc. recalled 48,110 units of the PERIFIX FX Continuous Epidural Anesthesia Tray nationwide to hospitals and surgical centers. The recall cites a potential for the lid of the catheter connector to be in the incorrect position. Hospitals and clinics should stop using the device and contact B Braun Medical for instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

HeartSine Pad-Pak Defibrillator Pads Recalled for 1,291,165 Units in 2025

HeartSine Technologies recalled 1,291,165 Pad-Pak defibrillator pads sold nationwide in the United States and worldwide. A defect may allow damage pins to disrupt the mechanical fit and electrical contact. Stop using the pads immediately and follow the manufacturer's recall instructions.

HeartSine Technologies
Due to
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical PERIFIX FX Epidural Tray Recalled for Lid-Position Issue (21,270 Units)

B Braun Medical recalled 21,270 PERIFIX FX Continuous Epidural Anesthesia Tray units distributed nationwide to hospitals and surgical centers after a lid-position defect was identified in the catheter connector. The defect allows the catheter connector lid to be in the incorrect position. Healthcare facilities and clinicians should stop using the device immediately and follow the manufacturer’s or

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical ESPOCAN Spinal/Epidural Tray Recalled Over Lid Position Risk

B Braun Medical recalled 10,130 ESPOCAN spinal/epidural trays nationwide after discovering potential for the catheter connector lid to be in an incorrect position. The recall covers multiple product codes and UDI numbers. Healthcare providers must stop using affected units and follow manufacturer instructions for remediation.

B BRAUN MEDICAL
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Cardinal Health 200 Salem Sump Anti-Reflux Valve Recalled for Breakage Risk (2025)

Cardinal Health 200, LLC recalls all lots of the Salem Sump Anti-Reflux Valve worldwide after complaints of valve breakage. The recall covers CE-marked valves with multiple identifiers. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. This notice alerts providers to check for the affected code and act now.

Cardinal Health
Firm has
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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Zenith Alpha 2 Thoracic Graft Recall Affects 695 Devices in 2025

Cook Medical recalled 695 Zenith Alpha 2 Thoracic Endovascular Grafts distributed to hospitals domestically and internationally. A defect could cause PTFE coating scrapings to be released during deployment, risking intravascular embolization. Healthcare providers and patients should stop using the device and follow the manufacturer’s recall instructions.

Cook Medical
Affected devices
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