FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline C-section procedure kits recalled for defective MASTISOL adhesive tubing
OTHERNationwide distribution
Stop using affected Medline C-section kits
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
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
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 Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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