Baxter Healthcare recalled 118 units of the Welch Allyn INF BAG, Model REF 5089-18, on October 28, 2025. The replacement bladder may contain a Large Adult size bladder instead of a Thigh size bladder. This defect poses a high risk for inaccurate blood pressure readings.
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Welch Allyn INF BAG, Thigh 1-Tube, Model REF 5089-18. Sold nationwide in California, Colorado, Ohio, and Utah, this product is part of a replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff.
The replacement bladder kit may contain the wrong size bladder. Using a Large Adult size bladder instead of a Thigh size bladder can lead to inaccurate blood pressure readings, which may affect patient care.
As of now, no injuries or incidents have been reported related to this recall. However, the potential for incorrect blood pressure measurements poses a serious risk.
Stop using the device immediately. Follow the recall instructions provided by Baxter Healthcare Corporation or your healthcare provider.
For more information, contact Baxter Healthcare Corporation directly or visit their website. You may also review the recall details at the FDA link provided.
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