FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline C-section procedure kits recalled for defective MASTISOL adhesive tubing
What this means
Medline distributed three types of medical procedure kits containing MASTISOL liquid adhesive where the tubing can crack when the vial is opened. This could prevent proper adhesive application during cesarean section procedures. No injuries have been reported.
- Check if your facility received any of these kit SKUs: DYNJ35494C, DYNJ38582O, or DYNJ82084F
- Verify lot numbers: 25KMD420, 25KMI679, or 25KMD145
- Stop using affected kits immediately
- Contact Medline or the FDA for return or replacement instructions
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
96 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1199-2026More 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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