Remel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
Remel, Inc is recalling 97 units of Campy CVA Medium 100/PK, lot R01272, due to customer complaints reporting low to no recovery of Campylobacter Jejuni ATCC 33291. The product was distributed nationwide in AZ, CO, IL, NJ, OH, TN, and WA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls are typically scored at 4 (Severe) when there are no reported illnesses but the product poses a risk of temporary or medically significant health consequences.
Plain-English summary
Remel, Inc is recalling 97 units of Campy CVA Medium 100/PK, product code R01272, lot 339135, which expired January 12, 2026. The recall is based on customer complaints reporting low to no recovery of Campylobacter Jejuni ATCC 33291 when tested on the identified lot of medium.
The affected product was distributed nationwide in the states of Arizona, Colorado, Illinois, New Jersey, Ohio, Tennessee, and Washington. The UDI-DI code for the product is 848838001055.
This is a Class II recall issued by the U.S. Food and Drug Administration. No illnesses or injuries have been reported in connection with this recall.
Consumers or facilities in possession of the recalled product should follow their standard procedures for handling recalled medical devices. For questions, contact Remel, Inc using the contact information provided in the official recall notice.
The recalled product
- Product
- Campy CVA Medium 100/PK, R01272
- Manufacturer
- Remel, Inc
- Affected units
- 97
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12
- 2026
Distribution
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