CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Welch Allyn INF, Thigh 1-Tube recalled by Baxter Healthcare

Baxter Healthcare is recalling Welch Allyn INF, Thigh 1-Tube, distributed nationwide in the US. The recall was initiated on 28 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI- 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
Quantity recalled118 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0847-2026
FDA event ID
97926
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
28 Oct 2025
FDA classified
1 Dec 2025
Reported
10 Dec 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

28 Oct 2025Recall initiated by company
1 Dec 2025Classified by FDA+34 days
10 Dec 2025Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide CaliforniaColoradoOhioUtah

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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