| | Class 2 Device Recall Remel Campy CVA Medium |  |
| Date Initiated by Firm | February 05, 2026 |
| Date Posted | February 26, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1474-2026 |
| Recall Event ID |
98403 |
| Product Classification |
Culture media, selective and non-differential - Product Code JSJ
|
| Product | Campy CVA Medium 100/PK, R01272 |
| Code Information |
UDI-DI 848838001055
Lot R01272 lot 339135
Expired January 12, 2026 |
| FEI Number |
1924669
|
Recalling Firm/ Manufacturer |
Remel, Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
| For Additional Information Contact | Erica Knox 800-255-6730 |
Manufacturer Reason for Recall | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. |
FDA Determined Cause 2 | Under Investigation by firm |
| Action | On February 5, 2026, the firm notified affected customers via Urgent Medical Device Recall letter. Customers were instructed to review test results and destroy any remaining inventory of the affected lot. |
| Quantity in Commerce | 97 |
| Distribution | US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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