FDA-Device2026-06-24Class IIPACKAGING DEFECT
Medline surgical convenience kits recalled for defective adhesive tubing
Medline surgical kits recalled for cracked adhesive tubing
Medline convenience kits used in robotic and laparoscopic surgery contain a recalled lot of adhesive from Ferndale Laboratories. The tubing in the adhesive applicator may crack during use, making the product unable to be applied properly during surgery.
- Check if your surgical kit matches one of the affected models and lot numbers listed in the recall
- Do not use kits with the affected lot numbers in surgical procedures
- Contact Medline or your hospital supply department for instructions on replacement kits
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: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2431-2026More 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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