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

2,324 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

LEASEIR Surgical Laser Recalled Over Missing Danger Label

LEASEIR recalled two MHR Xcell surgical laser devices on December 15, 2025. The console label for affected devices lacks a "DANGER" symbol, posing a high hazard risk. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

LEASEIR TECHNOLOGIES SLU
The console
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HIGHFDA DEVICE

SunMed Recalls Broselow Pediatric Emergency Tape Over Dosing Errors

SunMed Holdings recalled 95,300 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The tape contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Patients and healthcare providers must stop using the product immediately.

SunMed Holdings
Product contains
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HIGHFDA DEVICE

Broselow Recall Due to Dangerous Dosing Errors in ALS Organizer

Broselow recalled 384 units of their Domestic Complete ALS Organizer on December 15, 2025, due to harmful dosing errors. The recalled product affects dosages for Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the device immediately.

SunMed Holdings
Product contains
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HIGHFDA DEVICE

Hologic Recalls Brevera Breast Biopsy System Due to Contamination Hazard

Hologic, Inc. recalled 681,870 units of the Brevera Breast Biopsy System on December 15, 2025, due to presence of particulates that can enter breast tissue. The recall affects devices distributed nationwide in the U.S. Healthcare providers and patients must stop using the device immediately.

Hologic
Presence of
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HIGHFDA DEVICE

Integra LifeSciences Recalls Codman Microsensor Kit Over Corrosion Risk

Integra LifeSciences Corp. recalled 1,301 units of the Codman Microsensor Basic Kit on December 12, 2025. The recall follows reports of potential corrosion stains on the surface of the 14-gauge Tuohy Needle included in the kit. The affected units are distributed worldwide, including across all 50 U.S. states.

Integra LifeSciences Corp.
Potential corrosion
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HIGHFDA DRUG

Merck Recalls Noxafil Oral Suspension Due to Metal Contamination

Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.

NOXAFIL
Presence of
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HIGHFDA DRUG

Merck Emend Recalled Due to Potential Metal Contamination

Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.

EMEND
Presence of
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HIGHFDA DEVICE

Philips Recalls Azurion Systems Over Software Issues

Philips recalled 10,466 Azurion Systems on December 12, 2025, due to six software issues that can cause system failures. Users must stop using the devices immediately. The recall affects models sold worldwide, including in the U.S.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Six (6)
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HIGHFDA DEVICE

Integra LifeSciences Recalls ICP Sensor Kit Over Corrosion Risk

Integra LifeSciences Corp. recalled 5,116 units of the Codman CereLink ICP Sensor Basic Kit on December 12, 2025. The recall stems from potential corrosion stains on the included 14-gauge Tuohy needle. Healthcare providers and patients must stop using the device immediately and follow the recall instructions.

Integra LifeSciences Corp.
Potential corrosion
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HIGHFDA DEVICE

Philips Recalls Patient Monitors Over Connectivity Issue

Philips recalled 13,470 Smart-hopping 2.0 AP Patient Monitors on December 12, 2025. The MX40 device failed to reconnect to the PIC iX under certain conditions, posing a high risk to patient monitoring. Healthcare providers should stop using the device immediately and follow recall instructions.

Philips North America
It was
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HIGHFDA DEVICE

Medline Recalls Medical Kits Due to Adhesive Tubing Hazard

Medline Industries recalled 117 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive with defective tubing that may crack. Stop using these kits immediately and follow manufacturer instructions for return.

Medline Industries, LP
Medline kits
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HIGHFDA FOOD

House Of Flavors Recalls Banana Pudding Ice Cream Over Allergen Risk

House Of Flavors, Inc. recalled 2,388 units of 1972 Banana Pudding Ice Cream on December 12, 2025. The recall occurred due to undeclared soy lecithin, posing a risk to consumers with soy allergies. Products were distributed across 12 states including Alabama, Arizona, and New York.

House Of Flavors
Undeclared soy
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