stop use immediately Recalls

2,228 recalls tagged with “stop use immediately”.

Food & Beverages
HIGH
FDA FOOD

Gregory's Foods Cookie Dough Recalled for Undeclared Peanuts

Gregory's Foods recalled 308 cases of White Chocolate Macadamia Nut frozen cookie dough on December 19, 2025. The product contains undeclared peanuts, posing a serious allergy risk. Consumers should not consume the product and seek refunds.

Gregory's Foods
Undeclared peanuts.
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Health & Personal Care
HIGH
FDA DEVICE

Wondfo Streptococcal A At-Home Self-Test Recalled for FDA Clearance Issues (2026)

Wondfo recalled 188 units of Streptococcal A At-Home Self-Test sold nationwide in the United States after regulators found the device was not FDA-cleared. The recall centers on lack of FDA clearance for safety and effectiveness. Consumers should stop using the test immediately and contact Altruan GmbH or their healthcare provider for instructions.

Wondfo
Product not
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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

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Boston Scientific
Increased reports
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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 DEVICE

Boston Scientific Recalls AXIOS Stent Over Deployment Issues

Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Stent Recalled Over Deployment Issues

Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.

Boston Scientific
Increased reports
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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

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

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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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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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls Software Due to Lack of FDA Clearance

Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.

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

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.

INON ACE
Failed Disintegration
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Health & Personal Care
HIGH
FDA DEVICE

Altruan GmbH Clearest Strep-A Cassette Test Recall 188 Units (2025)

Altruan GmbH recalled 188 units of the Clearest Strep-A Cassette Test distributed nationwide in the United States after determining the device was not cleared by the FDA. The test lacks FDA clearance. Healthcare providers and patients should stop using the test immediately and follow the manufacturer’s recall instructions.

Altruan
Product not
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Interventional X-Ray System Over Safety Risk

Canon Medical System, USA recalled 3 interventional fluoroscopic x-ray systems on December 19, 2025. The recall follows reports that fixing screws in the ceiling movement gear may become loose, causing operational failures. Users should stop using the device immediately and follow provided instructions.

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

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall instructions.

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

Canon Medical System Recalls Interventional X-Ray Systems Over Safety Risk

Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.

Canon Medical System, USA
It has
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