FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline pelviscopy convenience kit recalled for defective adhesive tubing
What this means
Medline's SMSC-PELVISCOPY convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive. The tubing in these kits may crack when used, making the adhesive unusable for its intended application.
- Check if you have lot 25LMI820 (UDI-DI 10198459028274).
- Stop using affected kits and contact Medline or your supplier for instructions on replacement or return.
The agency's original wording
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution. OUS distribution pending.
Affected count
49,654 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2430-2026More 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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