FDA Medical Device Recalls (openFDA)
Remel, Inc: 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
- Recall number
- Z-0585-2026
- Recalling firm
- Remel, Inc
- Product
- 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
- Status
- Open, Classified
- Initiated
- 2025-11-12
- Posted
- 2025-11-21
- Terminated
- not on file
- Reason
- Products may contain contamination, which may result in a darker or brown media color.
- Root cause
- Under Investigation by firm
- Action
- On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.
- Quantity
- 1,000 US, 280 ROW
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.
- Lot, serial or model codes
- 1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287
- 510(k) numbers
- ["K790687","K802957"]
- PMA numbers
- not on file
- Product code
- JTZ
- 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