FDAHealthOctober 28, 2025
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.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 28, 2025
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
What's affected?
- 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.
- Lot code
- 23-296
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 118 units.
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