FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: 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.
- Recall number
- Z-0847-2026
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2025-10-28
- Posted
- 2025-12-01
- Terminated
- not on file
- Reason
- 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
- Process control
- Action
- 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
- Quantity
- 118 units
- Distribution
- US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28