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

Medline Catheters Recalled Over Infection Risk

Medline Industries recalled 228 lots of ReNewal Reprocessed Webster CS Catheters on December 22, 2025. These catheters may contain small particles that pose serious health risks, including systemic infection. Patients must stop using them immediately and follow the recall instructions.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DRUG

Baxter Healthcare Recalls Sterile Water for Irrigation Over Contamination

Baxter Healthcare Corporation recalled 125,496 bottles of Sterile Water for Irrigation on December 22, 2025. Plastic particles from the bottle rim contaminated the solution, posing a health risk. Consumers and healthcare providers must stop using the product immediately and seek guidance.

STERILE WATER
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Abbott Catheters Recalled Over Risk of Infection and Embolism

Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.

Medline Industries, LP
These lots
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Food & Beverages
HIGH
FDA FOOD

Fran's Chocolates Recalls Almondmilk Chocolate Over Hazelnut Risk

Fran's Chocolates recalled 112 units of its Almondmilk Chocolate on December 20, 2025. The product may contain undeclared hazelnuts, posing a serious risk to consumers with nut allergies. The recall affects products distributed in Colorado, Massachusetts, Nevada, Washington, and online.

Fran's Chocolates
undeclared hazelnut.
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Health & Personal Care
HIGH
FDA DEVICE

Tornier Recalls Surgical Screws Over Labeling Error

Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.

Tornier
A specific
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls HOT AXIOS Stent Over Deployment Issues

Boston Scientific recalled 266 units of the HOT AXIOS Stent on December 19, 2025. Reports indicated deployment and expansion problems, posing risks of prolonged procedures and additional surgical interventions. Consumers must stop using the device immediately and follow the manufacturer's instructions.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DRUG

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Failed Tablet/Capsule
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Food & Beverages
HIGH
FDA FOOD

Troemner Farm Recalls Cookies Over Undeclared Allergens

Troemner Family Farm recalled 56 units of Pfeffernusse Cookies on December 19, 2025, due to undeclared allergens. The cookies contain soy, wheat, and milk, posing a serious risk to consumers with allergies. The affected products were distributed in Michigan.

Troemner Farm
undeclared soy,
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue

Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Needles Free Access Devices Due to High Risk of Leakage

ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.

ICU Medical
Needle free
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Pulsator Arterial Blood Sampling Kit for Hazard

ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.

ICU Medical
Affected lots
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Health & Personal Care
HIGH
FDA DRUG

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.

ICU Medical
Affected lots
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Health & Personal Care
HIGH
FDA DEVICE

MicroPort Recalls HIPTURN Fem Head Trial Device Over FDA Violation

MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.

MicroPort Orthopedics
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Altruan GmbH Bisaf Strep A Self-Test Recalled for FDA Clearance Issue

Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.

Altruan
Product not
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

Tyber Medical recalled 64 units of the VOLT Wrist Treatment System on December 19, 2025. The recall affects model number 02.426.691S due to incorrect thread orientation in anatomical left plates. Patients and healthcare providers should stop using this device immediately.

Tyber Medical
The supplier
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