FDA-Device2026-02-04Class IIPACKAGING DEFECT

Medline surgical procedure kits recalled for defective adhesive tubing

OTHERNationwide distribution

Stop using Medline surgical procedure kits

Medline distributed medical procedure convenience kits containing MASTISOL liquid adhesive with a manufacturing defect. The adhesive vials have butyrate tubing that can crack when opened, potentially compromising the adhesive's sterility and usability during procedures.

  • Check if your facility received any of the eight Medline kit SKUs listed in the recall notice
  • Do not use affected kits; set them aside and do not open the MASTISOL adhesive vials
  • Contact Medline Industries for instructions on return or replacement
  • Verify lot numbers match those specified in the recall (ranging from 25KME682 to 25KMJ341)
Hazard

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Sold states
US Nationwide distribution.
Affected count
1,928 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2026

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