Medium risk Medical DevicesClass II

Medline Surgical Kits Mastisol Recall

Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395

Updated December 12, 2025

Medline medical procedure kits containing Mastisol liquid adhesive are being recalled because the tubing can crack when the adhesive vial is opened, potentially compromising the sterility and safety of surgical equipment.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on December 12, 2025. Details below.

What is recalled

Multiple Medline surgical procedure kits labeled with these SKUs: DYNJ0275635M, DYNJ0395037X, DYNJ04809N, DYNJ0565499AN, DYNJ27164Q, DYNJ40221G, DYNJ45311J, DYNJ46330C, DYNJ48980M, DYNJ52995F, DYNJ56483L, DYNJ61200B, DYNJ66150, DYNJ66630, DYNJ69065F, DYNJ69113C, DYNJ69401D, DYNJ81013D, DYNJ84275A, DYNJ88971, DYNJ89943, DYNJ900173J, DYNJ904945G, DYNJ909505D, DYNJ910543F, DYNJ910543G, DYNJT4724, DYNJT5184. Kit names include Watkins Spine Pack, SM-Spine Pack, Total Hip Pack, Laminectomy Pack, Knee Arthroscopy Pack, and others.

Am I affected

You're affected if you have a Medline medical procedure kit used in your healthcare facility with one of the SKU numbers listed in the recall (printed on the kit label).

What to do right now

Stop using affected Medline procedure kits immediately and contact Medline Industries to report the kit SKU number and arrange for return or replacement.

The hazard

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1200-2026
Classification
Class II
Recalled
December 12, 2025
Read the official notice

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