These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

630 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA DEVICE

Aesculap AG Recalls Surgical Instrument Due to Mislabeling

Aesculap AG recalled three surgical instruments on August 18, 2025, due to mislabeling issues. The ELAN 4 FIXED DURAGUARD LONG was incorrectly labeled as "Standard" and vice versa. The recall affects devices distributed in the U.S. and several international markets.

Aesculap AG
Mislabeling. The
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HIGHFDA DEVICE

CORNEAT VISION Recalls EverPatch+ Due to Conjunctival Wound Risk

CORNEAT VISION recalled 180 units of EverPatch+ on August 18, 2025, due to a risk of conjunctival wound dehiscence. This defect may lead to early exposure of the surgical patch. The recall affects distribution across the United States and several countries.

CORNEAT VISION
Reviewed complaints
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HIGHFDA DEVICE

CorNeat Vision Recalls Surgical Matrix Over High Dehiscence Risk

CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.

CorNeat Vision
Reviewed complaints
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HIGHFDA FOOD

Tampa Maid Foods Recalls Shrimp Due to Cesium-137 Contamination

Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp on August 16, 2025. The product may be contaminated with Cesium-137, a radioactive substance. Consumers should not eat the shrimp and should seek refunds or replacements.

TAMPA MAID FOODS
Product may
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HIGHFDA FOOD

TAMPA MAID FOODS Recalls Shrimp Due to Cesium-137 Contamination

TAMPA MAID FOODS recalled 31 cases of Breaded Butterfly Shrimp on August 16, 2025, due to potential contamination with Cesium-137. The product, sold in bulk packaging, may pose serious health risks. Consumers should not consume the shrimp and seek refunds immediately.

TAMPA MAID FOODS
Product may
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HIGHFDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluders Over High Hazard

Maquet Cardiovascular recalled the Heartstring III Proximal Seal System on August 15, 2025, due to three identified failure modes. These failures include issues with the seal's loading, deployment, and hemostasis. The recall affects 168 units distributed worldwide.

Maquet Cardiovascular
Three failure
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HIGHFDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Occluder Due to High Risk

Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to critical failure modes. The recall affects devices distributed globally since August 15, 2025. Users must stop using the device immediately and follow manufacturer instructions.

Maquet Cardiovascular
Three failure
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HIGHFDA DEVICE

Exactech Recalls Reverse Shoulder Humeral Liners Over Hazard

Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.

Exactech
Reverse Shoulder
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HIGHFDA DEVICE

Mindray Recalls BeneVision N1 Patient Monitor Over Alarm Issues

Mindray DS USA, Inc. recalled 2,278 BeneVision N1 Patient Monitors on August 15, 2025. The monitors may activate an abnormal alarm pause, compromising patient safety. Health professionals must cease using these devices immediately and follow recall instructions.

Mindray DS USA, Inc.
Potential for
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HIGHFDA FOOD

Great Value, Sea Best Frozen Shrimp Recalled Over Cesium-137 Risk

Beaver Street Fisheries recalled 33,164 pounds of Great Value and Sea Best raw frozen shrimp on August 15, 2025. The product may contain Cesium-137, a radioactive substance. Consumers should not consume the affected shrimp and should seek refunds.

Beaver Street Fisheries
Product may
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HIGHFDA DEVICE

ETHICON Recalls Tissue Control Device for Barb Non-Engagement Risk

ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.

ETHICON
Potential for
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HIGHFDA FOOD

Anderson Candy Company Recalls Peanut Rounds Over Soy Allergen Risk

Anderson Candy Company recalled 960,000 units of Peanut Rounds on August 15, 2025. The recall stems from undeclared soy allergens that pose a serious health risk. The affected products were distributed in several states including Texas and Louisiana.

Anderson Candy Company
Undeclared soy
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Recalled STWUQIKONG Spiral Tower Toy
HIGH
CPSC

STWUQIKONG Recalls Children's Toys Over Choking Hazard

STWUQIKONG recalled children's tower toys on August 14, 2025, due to a choking hazard. The toys contain small balls and violate the small ball ban, posing risks to children under three years. Consumers must stop using the toys immediately and return them for a full refund.

STWUQIKONG
The recalled
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