FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline hysterectomy kits recalled for defective adhesive tubing
What this means
Medline convenience hysterectomy kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The butyrate tubing in these kits may crack when used, making the adhesive unusable for application.
- Check if you have lot 25LMJ031 (UDI-DI 10195327024369)
- Do not use affected kits
- Contact Medline Industries for instructions on returns or replacements
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 kits: HYSTERECTOMY PACK-LF DYNJ20485L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2026More 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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