CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

Camhb W/lhb, Manual, 10/box Ycp112-10 Brucella Broth, 10/box Yt3450 recalled

Remel is recalling Camhb W/lhb, Manual, 10/box Ycp112-10 Brucella Broth, 10/box Yt3450, distributed nationwide in the US. The recall was initiated on 12 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Quantity recalled1,000 US, 280 ROW

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-0585-2026
FDA event ID: 97967
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Ongoing
Recall initiated: 12 Nov 2025
FDA classified: 21 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Nov 2025	Recall initiated by company
21 Nov 2025	Classified by FDA	+9 days
3 Dec 2025	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 contain contamination, which may result in a darker or brown media color.

Product as listed by the FDA

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

Where it was distributed

Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.

Nationwide Alaska California Florida Georgia Iowa Illinois Indiana Louisiana Massachusetts Maryland Maine Michigan Minnesota Nebraska New York Ohio Oklahoma Pennsylvania Rhode Island South Dakota

Questions about this recall

Why was it recalled?

Products may contain contamination, which may result in a darker or brown media color.

Which lots are affected?

1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Where was it sold?

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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