fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

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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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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Food & Beverages
HIGH
FDA FOOD

Black Sheep Egg Company Recalls 23,400 Dozen Free Range Eggs Over Salmonella Risk (2025)

Black Sheep Egg Company is recalling 23,400 dozen Free Range Grade AA Medium White Eggs sold at retail and wholesale locations in Arkansas and Missouri. The recall centers on potential Salmonella contamination. Consumers should not consume the eggs and should contact Black Sheep Egg Company for refund or replacement information.

Black Sheep Egg Company
Potential Salmonella
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Food & Beverages
HIGH
FDA FOOD

Black Sheep Egg Company Free Range Grade AA Eggs Recalled for Salmonella Risk (20,625 Dozen) 2025

Black Sheep Egg Company recalled 20,625 dozen eggs sold at retail and wholesale locations in Arkansas and Missouri after a potential Salmonella contamination. The eggs are Free Range Grade AA Large Brown, loose-packed in boxes. Consumers should not consume these eggs and should contact Black Sheep Egg Company for refunds or replacements.

Black Sheep Egg Company
Potential Salmonella
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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

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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Food & Beverages
HIGH
FDA FOOD

Black Sheep Egg Company Recalls 58,500 Dozen Free Range Eggs for Salmonella Risk (2025)

Black Sheep Egg Company recalls 58,500 dozen free range Grade AA medium brown eggs after FDA enforcement notice citing potential Salmonella contamination. The recall covers eggs sold in Arkansas and Missouri, with wholesale and broker locations in Mississippi, Texas, California and Indiana. Consumers should not eat these eggs and should contact Black Sheep Egg Company for refund or replacement.

Black Sheep Egg Company
Potential Salmonella
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Food & Beverages
HIGH
FDA FOOD

Black Sheep Egg Company Recalls 16,245 Dozen Free Range Eggs (18ct) 2025

Black Sheep Egg Company recalled 16,245 dozen Free Range Grade A Large Brown Eggs sold at retail locations in Arkansas and Missouri, and through wholesale brokers in Mississippi, Texas, California and Indiana. The cartons carry UPC 860010568538. Consumers should not eat these eggs and should contact Black Sheep Egg Company for refunds or replacements.

Black Sheep Egg Company
Potential Salmonella
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Food & Beverages
HIGH
FDA FOOD

Black Sheep Egg Company Recall: 288,900 Dozen Free Range Grade AA Eggs Over Salmonella Risk

Black Sheep Egg Company is recalling 288,900 dozen Free Range Grade AA Large Brown Eggs sold at retail and wholesale locations in Arkansas and Missouri, with broker distribution in Mississippi, Texas, California and Indiana. The recall cites potential Salmonella contamination as the hazard. Consumers should not consume these eggs and should contact Black Sheep Egg Company for refund or replacement

Black Sheep Egg Company
Potential Salmonella
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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 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 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

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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