FDA-Device2026-06-24Class IIPACKAGING DEFECT

Medline surgical convenience kits recalled for defective adhesive tubing

OTHERNationwide distribution

Medline surgical kits recalled for defective adhesive

Medline convenience kits containing a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive are being recalled. The adhesive's butyrate tubing can crack during use, making the adhesive unusable in surgical settings. About 50,000 kits across multiple surgical types are affected.

  • Check if your facility received one of the affected kit models and lot numbers listed in this recall.
  • Do not use affected kits in surgical procedures.
  • Contact Medline or your supplier for replacement or instructions on returning the kits.
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 kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK DYNJT6003 GV MACD PACK DYNJ46952M IMPLANT PACK - BBI AR DYNJ63508A KIT THORACOSCOPY DYNJ908872F LVAD TRAY DM1120A MAJOR UROLOGY PACK-LF DYNJ0368525M MICRODISECT DECOMPRESS-LF DYNJ911467 MINOR PACK DYNJ86972 MULTI PURPOSE PACK DYNJ58406B OPEN HEART DYNJ903245C P&K PACK DYNJT5838 PACK,PEDIATRIC MAJOR DYNJ906888F PCNL DYNJ904468C PEDIATRIC MINOR RFD DYNJ906296I PEDIATRIC PACK DYNJ54239K PEDIATRIC SURGERY DYNJ81474B PERLMUTTER PACK DYNJT7387 RFT ISC NOBLES MINOR PACK DYNJ43954B ROBOTICS FMOL LADY OF THE LAKE DYNJ89584 ROBOTICS PACK DYNJ83622B SCOLI PACK NTX DYNJ68415C SMALL ABDOMINAL PACK-LF PHS41749G STIM IMPLANT TRIALS DYNJ87790A SUPPLEMENTAL PACK DYNJ65244 TENEX PACK DYNDH2190 THORACIC PACK DYNJ56616G THORACIC PACK SHD DYNJ68416C THORACOSCOPY DYNJ9425843R THORACOTOMY PM DYNJ906815A THORACOTOMY THORACOSCOPY DYNJ902882D TRAY,NEONATAL PICC DRSG CHANGE DYNDC1533B UNIVERSAL-ASC DYNJ900071C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2026

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