Summary
The FDA issued a Class II for Campy CVA Medium 100/PK, R01272 by Remel, Inc. Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium..
Details
Source
Device Recall
External ID
Z-1474-2026
Action Date
2026-03-04
Status
Ongoing
Category
device
Product Description
Campy CVA Medium 100/PK, R01272
Lot/Code Info: UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026
Quantity Affected: 97
Reason for Recall
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Distribution
US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-05
Company
Lenexa, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel, Inc has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remel, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel, Inc have FDA actions?
Remel, Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1474-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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