FDA Medical Device Recalls (openFDA)
Medline Industries, LP: CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
- Recall number
- Z-1824-2026
- Recalling firm
- Medline Industries, LP
- Product
- CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
- Status
- Open, Classified
- Initiated
- 2026-03-16
- Posted
- 2026-04-16
- Terminated
- not on file
- Reason
- On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its sole consignee on 3/16/2026 via email. The notice explained the issue, potential risk of use, and requested the destruction of the affected product. The firm was also directed to notify anyone to whom the product was further distributed. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 640 kits
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Lot, serial or model codes
- Medline Kit Number/SKU CIT7050F, UDI/DI each 10198459536656, UDI/DI case 40198459536657, Lot Number 25KLA002
- 510(k) numbers
- ["K213481"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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