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Recall Observatory FDA recall evidence

Device 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.

Z-0847-2026

October 28, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97926
Status
Ongoing
Classification
Class II
Quantity
118 units
Official record key
device-enforcement:Z-0847-2026

Official wording

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.

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

Distribution pattern: US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.