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

2,251 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

Medline Medical Procedure Kits Recalled Due to Tubing Hazard

Medline recalled 96 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive with defective tubing that can crack during use. Patients and healthcare providers should stop using these products immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Philips Azurion System Recalled Due to Software Malfunction

Philips recalled 228 Azurion systems on December 12, 2025, due to software issues that may cause loss of X-ray functionality. The problems can result in incorrect image content and motorized movement failure. Affected devices were distributed internationally across multiple countries.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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HIGHFDA DEVICE

Medline Medical Kits Recalled Over Adhesive Tubing Risk

Medline Industries recalled 1,928 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive, which has defective butyrate tubing. Cracking during use poses a high risk to patients and healthcare providers.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Adhesive Tubing Hazard

Medline Industries recalled 1,928 medical procedure kits due to a safety hazard involving butyrate tubing. The recall affects multiple kit models containing MASTISOL liquid adhesive. The defective tubing may crack during use, posing a risk to patients and healthcare providers.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Hazardous Adhesive

Medline recalled multiple medical procedure convenience kits on December 12, 2025. The recall affects 66 units containing MASTISOL liquid adhesive. The adhesive's tubing may crack, posing a serious risk during use.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Over Adhesive Hazard

Medline Industries recalled select medical procedure convenience kits on December 12, 2025. The recall affects 40 units due to risks associated with MASTISOL liquid adhesive. The adhesive's tubing may crack during use, posing safety concerns.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Circumcision Kits Recalled Over Adhesive Hazard

Medline Industries, LP recalled 1,928 circumcision procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive, which may crack during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled Over Listeria Contamination

Prima Vera Nueva recalled 31,672 packages of Roasted Green Chile & Jack Cheese Tamales on December 12, 2025. The recall is due to potential contamination with Listeria monocytogenes, a harmful bacteria. Consumers should not consume the product and seek refunds or replacements.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Recalls Butternut Squash Tamales for Listeria Risk

Prima Vera Nueva recalled 18,876 packages of Butternut Squash Tamales on December 12, 2025, due to potential contamination with Listeria monocytogenes. The recall affects products distributed in California and Nevada. Consumers should not consume the tamales and seek refunds or replacements.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled for Listeria Risk

Prima Vera Nueva recalled 26,457 packages of Black Bean Bonanza Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes, a dangerous bacteria. Consumers should not consume the product and seek a refund or replacement.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled Due to Listeria Risk

Prima Vera Nueva recalled 27,964 packages of BBQ Chipotle Bean & White Cheddar Tamales on December 12, 2025. The recall affects products due to potential contamination with Listeria monocytogenes. Consumers should not eat the tamales and seek a refund or replacement.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled for Listeria Risk

Prima Vera Nueva recalled 9,656 packages of Roasted Pumpkin & White Cheddar Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes. Consumers should not eat these tamales and seek refunds immediately.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled Due to Listeria Risk

Prima Vera Nueva recalled 16,264 packages of Mushroom, Spinach & Salsa Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes, a serious foodborne illness. Consumers should not eat the product and seek a refund.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled for Listeria Contamination

Prima Vera Nueva recalled 21,705 packages of Roasted Green Chile Tamales on December 12, 2025, due to potential Listeria contamination. Consumers should not consume the product and should seek a refund or replacement. The tamales contain organic ingredients and were distributed in California and Nevada.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Tamales Recalled Due to Listeria Risk

Prima Vera Nueva recalled approximately 103,556 tamale packages on December 12, 2025, due to potential Listeria contamination. The recall affects Mushroom, Spinach & Salsa Tamales with 2 Cheeses sold in California and Nevada. Consumers should not eat these products and seek refunds immediately.

Prima Vera Nueva
Potential contamination
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HIGHFDA FOOD

Prima Vera Nueva Recalls Tamales Due to Listeria Risk

Prima Vera Nueva recalled 30,327 packages of Butternut Squash Tamales on December 12, 2025. The product poses a high risk of contamination with Listeria monocytogenes. Consumers should not consume these tamales and should seek a refund or replacement.

Prima Vera Nueva
Potential contamination
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Liquid Adhesive Hazard

Medline Industries, LP recalled 1,928 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive linked to cracking tubing during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
Read more
HIGHFDA DEVICE

Medline Medical Kits Recalled Over Hazardous Adhesive

Medline Industries recalled 236 medical procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive that may cause butyrate tubing to crack. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Adhesive Hazard

Medline Industries recalled 1,928 medical procedure convenience kits on December 12, 2025, due to a risk of crack in the adhesive tubing. The kits contain MASTISOL liquid adhesive, leading to safety concerns. Healthcare providers and patients should stop using the kits immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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