FDA-Device2026-02-18Class IIPACKAGING DEFECT
Medline Mercy Circumcision Tray recalled for potentially open ChloraPrep applicator seals
What this means
Medline Industries is recalling specific lots of Mercy Circumcision Tray kits because the BD ChloraPrep Triple Swabsticks inside may have open or compromised seals on their packaging. This could affect the sterility of the applicators before use. No injuries have been reported so far.
- Check if you have Medline Mercy Circumcision Tray, SKU CIT6135B, Lot 25EBC648
- Do not use kits from this lot
- Contact Medline Industries for a replacement or refund instructions
- Contact your healthcare provider if you have already used a kit from this lot
The agency's original wording
Hazard
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
168 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1336-2026More 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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