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Open, Classified

Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G

FDA Recall Z-2421-2026 · Posted 2026-06-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOGR
Date Initiated2026-04-27
Product Quantity49,654 kits total

Reason for Recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Firm Action

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution. OUS distribution pending.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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