FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for defective adhesive tubing
OTHERNationwide distribution
Medline surgical kits recalled for defective adhesive tubing
Multiple Medline surgical convenience kits contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive where the tubing may crack during use, making the adhesive unusable. This affects kits used in cardiac, vascular, and pacemaker procedures.
- Check if you have any affected Medline convenience kits listed in this recall.
- Do not use kits with the recalled adhesive lot in patient procedures.
- Contact Medline Industries or the FDA for instructions on returning or replacing affected 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: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2026More 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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