cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DRUG

Chlorpromazine Hydrochloride 200 mg Recall Expanded After Packaging Contamination Found in 3,363 JDS

Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal for guidance.

Chlorpromazine Hydrochloride
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ICEfx Cryoablation System Recalled for 19 Units Worldwide (2025)

Boston Scientific recalled 19 ICEfx Cryoablation System units worldwide, including the United States, Canada, France, Germany and Italy. The recall concerns desiccant tube subassemblies with end caps that were not tightened. Clinicians and patients should stop using the device immediately and follow recall instructions issued by the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DRUG

Amneal Chlorpromazine Hydrochloride 25 mg 100-count Recalled in 2025 for Packaging Contamination

Amneal Pharmaceuticals LLC is recalling 7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE tablets sold nationwide in the United States. Packaging coils used in the bottles tested positive for a microorganism, though no tablets were contaminated. Stop using this product immediately and contact Amneal or your healthcare provider for guidance.

Chlorpromazine Hydrochloride
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Preventive Maintenance Kit SPRPM8000 Recalled for Hazardous Defect

Boston Scientific recalled 1 unit of the Preventive Maintenance Kit SPRPM8000 after certain desiccant tubes were built with incorrectly tightened end caps. This assembly defect can lead to device malfunction, posing a serious risk to patients. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DRUG

B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter

B. Braun Medical recalled 46,032 containers of Lactated Ringers Injection USP sold nationwide in the United States. The recall cites the presence of particulate matter in the 1000 mL IV solution. Consumers should stop using the product immediately and contact their healthcare provider or B. Braun for guidance.

B Braun Medical
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Aesculap AG Recalls ELAN 4 Fixed Duraguard Long Mislabeling Devices (GB943R)

Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.

Aesculap AG
Mislabeling. The
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Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision EverPatch Recalled for Conjunctival Wound Dehiscence Risk (630 Units, 2025)

CorNeat Vision recalled 630 EverPatch surgical matrices distributed worldwide, including in 28 U.S. states. Review of complaints found conjunctival wound dehiscence may lead to early exposure of the patch. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact CORNEAT VISION, LTD. or your healthcare provider for guidance.

CorNeat Vision
Reviewed complaints
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Health & Personal Care
HIGH
FDA DEVICE

Aesculap ELAN 4 Fixed Duraguard Recalled for Mislabeling (1 Unit, 2025)

Aesculap AG is recalling one unit of the ELAN 4 Fixed Duraguard Standard, model GB942R, distributed in the United States to Missouri and internationally to multiple countries. The recall addresses mislabeling where the Standard was labeled as Long and the Long was labeled as Standard. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall指南

Aesculap AG
Mislabeling. The
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Food & Beverages
HIGH
FDA FOOD

ADMIRAL OF THE FLEET, PORTICO SEAFOOD CLASSIC Breaded Shrimp Recalled Over Cs-137 Contamination (120

ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC Cleantail Breaded Butterfly Shrimp is recalled by TAMPA MAID FOODS, LLC after the FDA identified Cesium-137 contamination. The recall covers 1,200 cases distributed to multiple states. Consumers should not consume the product and should contact TAMPA MAID FOODS for refund or replacement.

ADMIRAL OF THE FLEET
Product may
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Food & Beverages
HIGH
FDA FOOD

Tampa Maid Foods Frozen Shrimp Recalled for Cs-137 Contamination (2025)

Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.

TAMPA MAID FOODS
Product may
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe 61,334 Reverse Shoulder Humeral Liners Recalled Worldwide (2025)

Exactech recalled 61,334 Equinoxe reverse shoulder humeral liners sold worldwide after finding the articular surface position outside labeling dimensions. The recall covers REF 320-38-00, REF 320-38-03, REF 320-42-00, and REF 320-42-03. Healthcare providers and patients should stop using the devices immediately and follow recall instructions distributed by email.

Exactech
Reverse Shoulder
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Proximal Seal System 3.8 mm Occluder (32,867 Units) 0

Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer recall instructions.

Maquet Cardiovascular
Three failure
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Food & Beverages
HIGH
FDA FOOD

Anderson Candy Company Recalls 960,000 Peanut Rounds for Undeclared Soy Allergen (2025)

Anderson Candy Company recalled 960,000 Peanut rounds after undeclared soy allergen was found. The sizes are 2.25 oz and 3 oz. The affected distribution covers Oklahoma, Louisiana, Texas, Arkansas, Kansas, Missouri, Arizona, Alabama, Mississippi and Tennessee. Consumers should not eat the product and should contact the company for refund or replacement.

Anderson Candy Company
Undeclared soy
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Heartstring III Proximal Seal System Recalled for 168 Units Worldwide (2025)

Maquet Cardiovascular recalled 168 Heartstring III Proximal Seal System intravascular occluders worldwide, including the United States. Three failure modes have been identified: loading the Heartstring Seal, deploying it into the aortotomy, and achieving adequate hemostasis. Healthcare facilities should stop using the device and follow the manufacturer’s recall instructions.

Maquet Cardiovascular
Three failure
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Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Recalled 11,542 HumeraL Liners Worldwide Over Dimension Mismatch (2025)

Exactech recalled 11,542 Equinoxe reverse shoulder humeral liners worldwide after finding the articular surface position outside labeling specifications. The recall covers several REF numbers and UDIs and is active as of 2025. Healthcare providers were advised to stop using affected liners and follow manufacturer instructions.

Exactech
Reverse Shoulder
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Food & Beverages
HIGH
FDA FOOD

Great Value and Sea Best Raw Frozen Shrimp Recalled for Cs-137 Contamination (33,164 Lbs) 2025

Beaver Street Fisheries is recalling 33,164 pounds of Great Value and Sea Best raw frozen shrimp distributed to Arkansas, Florida and Illinois after Cs-137 contamination was detected. The product may be contaminated with Cesium-137, a radiological hazard. Consumers should not consume it and should contact Beaver Street Fisheries for refund or replacement.

Great Value
Product may
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Recalled Firefly Safe & Green 32 oz. fuel bottles
HIGH
CPSC

Firefly Safe & Green 32 oz. Fuel Bottles Recalled for Poisoning Risk to Children

Firefly Fuel Inc. recalled Firefly Safe & Green 32 oz. bottles. The recall date is August 14, 2025. The fuel is sold in a clear bottle with a white cap and nozzle applicator. The product label shows Firefly brand, Safe & Green in green font, and claims Non-Toxic and Kosher. The nozzle applicator lacks child-resistant features, violating the Poison Prevention Packaging Act and the Federal Hazardous

Firefly Fuel
The recalled
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