burn risk Recalls

448 recalls tagged with “burn risk”.

Health & Personal Care
HIGH
FDA DEVICE

Philips North America Issues Recall for Patient Information Center Software

Philips North America recalled 146 units of Patient Information Center software on December 22, 2025. A software patch modifies Mobile Event Notification filter settings without notifying users. The recall affects units distributed worldwide, including 41 in the U.S.

Philips North America
A recent
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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 MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.

Canon Medical System, USA
There is
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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

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

Rifton Recalls E-Pacer Gait Training Device Over Fraying Risk

Rifton Equipment recalled 470 E-Pacer gait training devices on December 18, 2025. The body support strap may fray, posing a risk to users. Health care providers and patients must stop using the device immediately.

Community Products
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Wilson-Cook Medical Recalls Bipolar Sphincterotomes Due to Hazard

Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.

Wilson-Cook Medical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Aju Pharm Recalls AlternatiV+ Max Knotless Anchor Due to Device Failures

Aju Pharm Co. recalled 2,569 units of the AlternatiV+ Max Knotless Anchor on December 17, 2025, following reports of device failures. Issues include anchor breakage and suture breakage, posing significant risks to patients. Consumers should stop using the device immediately and follow recall instructions.

Aju Pharm Co.
Reports of
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Health & Personal Care
HIGH
FDA DEVICE

Aju Pharm Recalls Fixone Hybrid Anchor Due to Device Failures

Aju Pharm Co. recalled 233 Fixone Hybrid Anchors on December 17, 2025, due to multiple reports of device failures. The issues include anchor breakage, bending, and suture breakage. Patients and healthcare providers must stop using the device immediately.

Aju Pharm Co.
Reports of
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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 DEVICE

Medline Medical Kits Recalled Due to Suction Irrigator Hazards

Medline recalled 41,432 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak or emit vaporized saline. This defect poses a high risk of injury during medical procedures.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Procedure Kits Due to Leakage Risk

Medline Industries recalled 12,584 medical procedure convenience kits on December 16, 2025. The recall stems from design changes in Stryker's Strykeflow 2 Suction Irrigators that can lead to leaks or vaporized saline emissions. Healthcare providers and patients must stop using the devices immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medical Kits Recalled Over Strykeflow 2 Suction Hazard

Medline recalled 4,536 medical procedure kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. The recall affects various models used in surgeries nationwide.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Kits Due to Suction Irrigator Leak Hazard

Medline Industries recalled 96 medical procedure convenience kits on December 16, 2025. The recall affects kits containing Stryker's Strykeflow 2 Suction Irrigators due to a design flaw causing leaks. Patients and healthcare providers must stop using these kits immediately.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Kits Over High Burn Risk

Medline Industries recalled 1,457 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. Healthcare providers and patients must stop using the devices immediately.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Laser Probes Due to Infection Risk

Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must stop using these devices 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 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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