Recall Z-0847-2026 ยท DXQ Blood Pressure Cuff
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.
| Date | Dec 1, 2025 (initiated Oct 28, 2025) |
| Status | Open, Classified |
| 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 cor |
| Quantity | 118 units |
| Distribution | US Nationwide distribution in the states of California, Colorado, Ohio, and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.