CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report

Yeastone Broth, 10/BOX YY3462 recalled by Remel

Remel is recalling Yeastone Broth, 10/BOX YY3462, distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

Quantity recalled2819

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-1806-2026
FDA event ID: 98616
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Ongoing
Recall initiated: 24 Mar 2026
FDA classified: 10 Apr 2026
Reported: 22 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Mar 2026	Recall initiated by company
10 Apr 2026	Classified by FDA	+17 days
22 Apr 2026	Published in enforcement report	+12 days

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

Reason for recall

Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.

Product as listed by the FDA

Yeastone Broth, 11ML, 10/BOX YY3462

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.

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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