FDA-Device2026-04-22Class IIPROCESSING DEFECT
Medline CENTURION Circumcision Kit recalled for lack of sterilization
What this means
Medline distributed one lot of CENTURION Circumcision Kits (lot number 25KLA002) without completing the required sterilization process. This means the kits are not sterile and could pose an infection risk if used. The affected kits were distributed in South Carolina.
- Do not use kit lot number 25KLA002 (Medline SKU CIT7050F).
- Contact Medline Industries or your supplier immediately if you have this lot.
- Return the kits to your distributor or Medline for a replacement.
The agency's original wording
Hazard
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of South Carolina.
Affected count
640 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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