cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

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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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 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 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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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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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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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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Recalled IcyBreeze Buddy Portable Misting Fan in slate blue
HIGH
CPSC

IcyBreeze Recall Expands Over Fire Hazard Risk in Portable Misting Fans (2025)

IcyBreeze recalled the IcyBreeze Buddy portable misting fan due to a charging fire hazard. The recall affects consumers who own the IcyBreeze Buddy with a 1.5-liter water tank and a 10,000 mAh lithium-ion battery. Affected units must be returned for a full refund and disposal guidance. Call 817-900-2664 or visit the recall page to begin the process and receive a $150 credit at Solo Brands brands.

IcyBreeze Cooling
The misting
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Recalled Five Below Tabletop Fire Pit – smooth model
HIGH
CPSC

Five Below Recalls Tabletop Fire Pits for Risk of Serious Burn Injury

Five Below recalls two tabletop fire pits after reports of alcohol fuel flames jetting and spreading. The recall affects devices sold nationwide. Stop using the recalled pits immediately and contact Five Below for a refund. Full refunds available or $5 option; mail-back refunds possible with photo submission.

Five Below
Alcohol fuel
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems LOGIQ P10 Ultrasound System Recalled for UGAP Data Inaccuracy (31 Units, 2025)

GE Medical Systems recalled 31 LOGIQ P10 R4.5 HD ultrasound systems sold nationwide in the United States and globally after discovering UGAP measurements may misstate liver steatosis. The UGAP data may display inaccurate values representing liver steatosis. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions.

GE Medical Systems
The Ultrasound-Guided
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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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Food & Beverages
HIGH
FDA FOOD

Kirkland Signature Ahi Tuna Wasabi Poke Recalled Over Listeria Risk

Kirkland Signature Ahi Tuna Wasabi Poke sold at Costco is recalled after a Listeria monocytogenes positive test in green onions used in the product. Western United Fish Company initiated the recall. Consumers should not eat the product and should seek refunds or replacements.

Kirkland Signature
Listeria monocytogenes.
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