—#217194

Product

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

FDA product code: DXQ — Blood Pressure Cuff
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: UDI- DI 00732094110845, Lot Numbers: 23-296, 23-318, 23-325, 23-353, 24-008, 24-036, 24-037, 24-138, 24-183, 25-037, 25-112, 25-119, 25-180

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 11/7/2025 via USPS first class mail. The notice explained the issue, hazard involved and requested the following: For unopened kits: Please inspect any unopened replacement bladder kits you may have. If the product code and lot number (please refer to Figure 1 on page 2 of this letter) on the replacement bladder kit label match those listed in the table above, contact Baxter Technical Support to arrange for return and replacement. For any Thigh size two-piece reusable blood pressure cuffs: Visually confirm the correct dimensions of the bladder; please disregard the lot number printed directly on the bladder. If an incorrect bladder is identified, please contact Baxter Technical Support to arrange for a return and replacement. Contact Baxter Technical Support to arrange for return and replacement product at 800-535-6663 between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday. Press option 2, then select option 1 or 2 for language preference, then press option 2. - If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for the return and exchange of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. - Please forward a copy of this communication to the office manager, facility risk manager, patient safety manager, biomedical engineering department, and any other departments within your institution that use the affected product. - If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) and you have affected product please do not distribute. Contact Baxter Technical Support for additional instructions. - If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distribut

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.

Timeline

Recall initiated: 2025-10-28
Posted by FDA: 2025-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.