The Recall Desk
Severity pendingFDA (Devices)·Z-0847-2026·Announced 2025-12-10

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder f

Pending LLM rewrite. Source: FDA_DEVICE Z-0847-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

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.
Manufacturer
Baxter Healthcare Corporation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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

Distribution

Distributed nationwide across the United States.