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

3,615 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
Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls 25GA Backflush Pouches Over Infection Risk

Vortex Surgical recalled 14,789 surgical backflush pouches on December 16, 2025, due to compromised sterile barriers. The recall affects catalog numbers VS0270.25 and VS0275.27, with potential for bioburden contamination. Healthcare providers and patients should stop using these devices immediately.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Polisher Recalled Due to Infection Risk

Vortex Surgical recalled 14,789 Tecfen Retractable Membrane Polishers on December 16, 2025. The recall stems from potential voids in Tyvek pouches that may compromise sterility and lead to bioburden contamination. Healthcare providers and patients must stop using the products immediately.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Injection Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Due to Missing Imprint

SpecGx LLC recalled 287,988 bottles of Oxycodone and Acetaminophen tablets on December 16, 2025. The tablets may lack proper imprinting, posing risks for misuse and confusion. Healthcare providers and consumers must stop using the product immediately and seek guidance.

SpecGx LLC
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Vitrectomy Lenses Due to Infection Risk

Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices immediately.

Vortex Surgical
There may
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Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Over Missing Imprint

SpecGx LLC recalled 74,544 bottles of Oxycodone and Acetaminophen Tablets on December 16, 2025. The tablets may lack an imprint, raising serious identification issues. Consumers should stop using these medications immediately and contact their healthcare providers for guidance.

OXYCODONE AND ACETAMINOPHEN
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

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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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Plum Duo IV Pump Due to High Hazard

ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer instructions.

ICU Medical
Plum Solo
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Plum Duo Infusion System Over Speaker Failure

ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.

ICU Medical
ICU Medical
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Diagnostica Stago Recalls Asserachrom HPIA Kit Over False Negatives

Diagnostica Stago issued a recall for 438 Asserachrom HPIA kits on December 15, 2025. The kits, used to detect PF4 antibodies, may produce false negative results. The affected lot is 271288, distributed worldwide including multiple U.S. states.

Diagnostica Stago
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

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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Health & Personal Care
HIGH
FDA DRUG

Novadoz Pharmaceuticals Recalls Glycopyrrolate Oral Solution Over Safety Concerns

Novadoz Pharmaceuticals LLC recalled Glycopyrrolate Oral Solution on December 15, 2025, due to failed impurities and degradation specifications. The recall affects Rx only products manufactured by MSN Pharmaceuticals Inc. Consumers should stop using this medication immediately.

GLYCOPYRROLATE
Failed Impurities/Degradation
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Food & Beverages
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical IV Pump Recalled Due to Programming Error Risk

ICU Medical recalled its Plum Solo and Duo Infusion pumps on December 15, 2025, after reports of programming errors. The pumps can fail to flush properly after piggyback therapy, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.

ICU Medical
Plum Solo
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Plum Duo Infusion Pump Over High Hazard Risk

ICU Medical recalled the Plum Duo Infusion Pump on December 15, 2025, after reports of malfunctioning flush programming. The recall affects models 400020401 and 400021001 sold worldwide. This issue may pose a high risk to patient safety.

ICU Medical
Plum Solo
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