FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline medical procedure kits recalled for defective MASTISOL adhesive tubing
OTHERNationwide distribution
Stop using affected Medline procedure kits
Medline distributed eight types of medical procedure convenience kits that contained MASTISOL liquid adhesive with a manufacturing defect. The tubing in the adhesive vials can crack when opened, which could affect the sterility or usability of the kit during medical procedures.
- Check if you have any of the eight affected Medline kit SKUs listed in this recall
- Do not use kits with lot numbers matching the recalled batches
- Contact Medline or your healthcare facility's supply chain to return or dispose of affected kits
- Verify lot numbers before using any remaining Medline procedure kits from this period
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
66 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2026More 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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