FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for defective adhesive tubing
Medline surgical kits recalled for adhesive tubing defect
Medline Industries issued a recall of nearly 50,000 surgical convenience kits because they contain a defective lot of Mastisol Liquid Adhesive made by Ferndale Laboratories. The tubing on the adhesive dispenser may crack when used, making the product unusable during surgery.
- Check your surgical kit against the list of affected lot numbers and UDI codes on the FDA website.
- Do not use affected kits in surgical procedures.
- Contact Medline Industries or your supplier for instructions on replacement or return.
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Who it affects
Adults
Illnesses reported
None reported
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: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2421-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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