CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report

Campy CVA Medium, R01272 recalled by Remel

Remel is recalling Campy CVA Medium, R01272, distributed nationwide in the US. The recall was initiated on 5 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026
Quantity recalled97

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-1474-2026
FDA event ID
98403
Recalling firm
Remel, Lenexa, KS
Classification
Class II
Status
Ongoing
Recall initiated
5 Feb 2026
FDA classified
26 Feb 2026
Reported
4 Mar 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

5 Feb 2026Recall initiated by company
26 Feb 2026Classified by FDA+21 days
4 Mar 2026Published in enforcement report+6 days

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

Reason for recall

Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.

Product as listed by the FDA

Campy CVA Medium 100/PK, R01272

Where it was distributed

US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.

Nationwide ArizonaColoradoIllinoisNew JerseyOhioTennesseeWashington

Questions about this recall

Why was it recalled?

Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.

Which lots are affected?

UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026

Where was it sold?

US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.

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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