FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline neuro surgical kits recalled for defective adhesive tubing
OTHERNationwide distribution
Medline neuro kits recalled for defective adhesive
Medline Industries recalled multiple neurosurgery convenience kits because they contain a defective lot of MASTISOL Liquid Adhesive from Ferndale Laboratories. The tubing in the adhesive applicator may crack when used, making the product unusable for the procedure.
- Check if you have one of the affected kit model numbers listed in the recall.
- Do not use the kit if you have an affected lot number.
- Contact Medline Industries for instructions on how to return or replace the kit.
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
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 kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2428-2026More Medline Industries, LP recalls
- FDA-Device2026-06-24Medline medical procedure kits recalled for catheter defects and connector detachment risk
- FDA-Device2026-06-24Medline cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline dressing change kits recalled for defective adhesive tubing
- FDA-Device2026-06-24Medline open-heart and cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline laparoscopy procedure kits recalled for catheter defects
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