Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.
Inflation device handle may detach from the syringe during procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the Allwell Inflation Device for angiographic use, REF: IS-30-A. The affected lot numbers include I2559701, I2563344, and others. The devices were distributed worldwide.
The device's handle may detach from the syringe during use, which can result in potential complications during medical procedures. This defect poses a high risk to patients' safety.
As of the recall date, there have been no reported injuries or deaths associated with this defect. However, the potential for significant harm exists if the device fails during a procedure.
Stop using the Allwell Inflation Device immediately. Contact Merit Medical Systems or your healthcare provider for further instructions. Follow any recall instructions provided by the manufacturer.
For inquiries, contact Merit Medical Systems, Inc. by email or through their official website. More details can be found at the FDA recall page.
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