FDA Medical Device Recalls (openFDA)
Remel, Inc: Campy CVA Medium 100/PK, R01272
- Recall number
- Z-1474-2026
- Recalling firm
- Remel, Inc
- Product
- Campy CVA Medium 100/PK, R01272
- Status
- Open, Classified
- Initiated
- 2026-02-05
- Posted
- 2026-02-26
- Terminated
- not on file
- Reason
- Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- Root cause
- 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
- 97
- Distribution
- US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.
- Lot, serial or model codes
- UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSJ
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28