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

2,247 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

American Contract Systems Recalls Radiology Packs Over Sterilization Issues

American Contract Systems recalled 32,433 radiology packs on September 4, 2025, due to improper sterilization. The products were re-gassed after a nonconformance in the initial Ethylene Oxide gas injection process. Their safety and effectiveness remain unverified after multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Convenience Kits Due to Sterilization Risk

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025, due to improper sterilization. The affected products were re-gassed and not validated for safety after multiple sterilization cycles. Distribution occurred nationwide, including states such as South Dakota and Illinois.

American Contract Systems
Identified products
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows issues with multiple sterilization cycles that compromise product safety. Patients and healthcare providers should stop using these devices immediately.

American Contract Systems
Identified products
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HIGHFDA FOOD

Pacific Coast Producers Recalls Canned Pears Over Lead Contamination

Pacific Coast Producers recalled 1,836 cases of canned pears on September 4, 2025, due to potential lead contamination. The affected product includes pears in pear juice concentrate sold in 15-ounce cans. Consumers should not consume the product and seek refunds immediately.

Pacific Coast Producers
Potential contamination
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HIGHFDA FOOD

Organicare Nature's Science Recalls FemiClear Supplement Over E. Coli Risk

Organicare Nature's Science recalled 15,075 bottles of FemiClear Daily Bladder Strength Dietary Supplement on September 4, 2025. The recall stems from microbial contamination with E. coli O7:K1 and E. coli 1303. Consumers should not consume the product and seek refunds immediately.

Organicare Nature's Science
Microbial contamination
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HIGHFDA DEVICE

American Contract Systems Biopsy Tray Recalled Over Sterilization Issues

American Contract Systems recalled 32,433 Basic Biopsy Trays on September 4, 2025. The recall resulted from products being re-gassed after a sterilization failure. The company cannot confirm the safety or effectiveness of these devices after multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Safety Risk

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. These kits failed to meet safety standards due to improper sterilization processes. The recall affects multiple states, including South Dakota and Iowa.

American Contract Systems
Identified products
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HIGHFDA FOOD

Wegmans Recalls Fruit Cocktail Due to Lead Contamination Risk

Wegmans Food Markets recalled 609 cases of Fruit Cocktail on September 4, 2025, due to potential lead contamination. The affected product includes diced peaches and pears, distributed across multiple states. Consumers should not consume the recalled product and seek a refund or replacement.

Pacific Coast Producers
Potential contamination
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HIGHFDA FOOD

Wegmans Recalls Halved Pears Due to Lead Contamination Risk

Wegmans Food Markets recalled 102 cases of halved pears in pear juice on September 4, 2025. The recall follows concerns of potential lead contamination. Consumers should not consume the product and seek refunds.

Pacific Coast Producers
Potential contamination
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HIGHFDA DEVICE

American Contract Systems Recalls Medical Kits Over Sterilization Issues

American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows the identification of products that were re-gassed after sterilization failures. The safety and effectiveness of these products cannot be confirmed due to multiple sterilization cycles.

American Contract Systems
Identified products
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HIGHFDA DEVICE

Lutronic Recalls Electrosurgical Unit Due to Defect Risks

Lutronic recalled 7,490 units of the XERF EFFECTOR 60 electrosurgical unit on September 4, 2025. Manufacturing defects may lead to adverse events for patients. Devices manufactured between April 1, 2025, and August 20, 2025, are affected.

Lutronic
Manufacturing defects
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HIGHFDA DRUG

Zydus Lifesciences Recalls Chlorpromazine Tablets Over Contaminant Hazard

Zydus Lifesciences recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects tablets with NDC 16714-051-01 due to N-Nitroso Desmethyl Chlorpromazine exceeding acceptable limits. Consumers should stop using the product immediately and consult healthcare providers.

Zydus Lifesciences
CGMP Deviations:
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