Z-1824-2026Class II

CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

Name: Z-1824-2026 CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Creator: Medline Industries, LP
Published: 2026-03-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-16 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F on 2026-03-16. FDA classified it as Class II and gives the reason as "On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1824-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-16
Posted: 2026-04-16
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Product code: LRO General Surgery Tray
Reason for recall: On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Root cause tag: sterility
FDA 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 [email protected].
Quantity in commerce: 640 kits
Distribution: US Nationwide distribution in the state of South Carolina.
Product codes and lots: Medline Kit Number/SKU CIT7050F, UDI/DI each 10198459536656, UDI/DI case 40198459536657, Lot Number 25KLA002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-16

Product code LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)