Z-0847-2026 Class II Ongoing
FDA device recall Z-0847-2026 was initiated by Baxter Healthcare Corporation on Oct 28, 2025 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 118 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 10, 2025
- Initiation Date
- Oct 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 units
Product description
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.
Reason for recall
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.
Distribution pattern
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0847-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026