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

Philips Recalls Allura Xper FD20 Biplane Over Electrical Hazard

Philips recalled 18 Allura Xper FD20 Biplane systems on December 15, 2025, due to an electrical hazard. The drip tray beneath the cooling unit may not have been installed, risking coolant contact with electrical components. This issue could cause electrical short circuits and system shutdowns.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Philips Medical Systems Recalling Allura Xper FD10 Over Electrical Risk

Philips Medical Systems Nederland B.V. recalled 56 Allura Xper FD10 systems on December 15, 2025. The recall stems from a potential electrical hazard where coolant may contact electrical components, risking short-circuits. Healthcare providers must cease use immediately and follow provided instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Philips Recalls Allura Xper FD20 Over Electrical Hazard

Philips recalled 79 Allura Xper FD20 systems on December 15, 2025. The recall affects systems with an improperly installed drip tray which can cause electrical short-circuits. Healthcare providers and patients must stop using the device immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Philips Medical Systems Recalls Allura Xper FD20/20 Over Electrical Hazard

Philips Medical Systems Nederland B.V. recalled the Allura Xper FD20/20 medical imaging system on December 15, 2025, due to a potential electrical hazard. The recall affects eight units globally, including those distributed in the United States and several other countries. A missing drip tray can lead to coolant contacting electrical components, posing a risk of electrical short circuits and total

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

Philips Medical Systems Issues Recall for Allura Xper FD10/10

Philips Medical Systems recalled 21 units of the Allura Xper FD10/10 system on December 15, 2025. A defect in the drip tray could cause coolant to contact electrical components, posing a high risk of electrical short-circuits. Users should stop using the device immediately and follow recall instructions.

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

Philips Recalls Allura Xper FD10C Systems Over Electrical Hazard

Philips recalled 38 Allura Xper FD10C systems on December 15, 2025, due to a potential electrical hazard. The drip tray beneath the cooling unit may not have been properly installed, risking coolant contact with electrical components. This could lead to electrical shorts and system shutdowns.

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

Philips Medical Device Recalled Due to Electrical Hazard

Philips recalled 95 Allura Xper FD10 systems on December 15, 2025. The recall resulted from missing or improperly documented installation of the drip tray, posing an electrical hazard. Users should stop using the device immediately and follow the manufacturer’s instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Philips Medical Systems Recalls Allura Xper FD20 Over Electrical Hazard

Philips Medical Systems recalled 143 Allura Xper FD20 systems on December 15, 2025, due to a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, risking coolant contact with electrical components. Users must stop using the device immediately and follow recall instructions.

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

Philips Recalls Allura Xper FD10F Systems Due to Electrical Hazard

Philips Medical Systems recalled 12 Allura Xper FD10F systems on December 15, 2025, after identifying a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, posing a risk of coolant leakage and electrical short-circuits. Users must stop using the device immediately and follow recall instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Intuitive Surgical Recalls da Vinci SP Access Port Kits Over Sterility Risk

Intuitive Surgical recalled 41,526 da Vinci SP Access Port Kits on December 15, 2025, due to potential cracks in the tray that could breach sterility. The recall affects models 430073 and 430075, distributed worldwide including across the US and various countries. Patients and healthcare providers must stop using these devices immediately and follow manufacturer instructions for return.

Intuitive Surgical
Access Port
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HIGHFDA FOOD

So Delicious Dairy Free Frozen Dessert Recalled Due to Foreign Material

So Delicious Dairy Free recalled 4,665,608 units of its Salted Caramel Cluster Cashewmilk frozen dessert on December 15, 2025. The recall follows the discovery of foreign material in the product. Consumers should not consume this item and seek a refund or replacement immediately.

WhiteWave - Louisville Pilot Plant
Foreign material
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HIGHFDA DEVICE

Philips Medical Imaging System Recalled Over Electrical Hazard

Philips recalled 14 units of the Allura Xper FD10/10 due to a potential electrical hazard. The recall affects medical imaging systems distributed worldwide. If the drip tray beneath the cooling unit is not installed, coolant may contact electrical components, leading to system shutdown.

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

Broselow Pediatric Emergency Tape Recalled Over Dosing Errors

SunMed Holdings recalled 20,583 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The product contains harmful dosing errors for critical medications including Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the tape immediately and follow recall instructions.

SunMed Holdings
Product contains
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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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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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