FDA-Device2026-06-24Class IIPACKAGING DEFECT

Medline hysterectomy kits recalled for defective adhesive tubing

OTHERNationwide distribution

Medline hysterectomy kits recalled for adhesive tubing defect

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
Hazard

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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-2447-2026

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