Class II U.S. Food and Drug Administration

Medline convenience kits: Discectomy Pack Dynj86476B EAR Dynj81460C recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive

Recall published 4 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2421-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
49,654 kits total
Distribution
Nationwide
Made in
United States
Lot / code info
DYNJ86476B UDI-DI 10198459440366 Lot 25KBL478 DYNJ81460C UDI-DI 10198459434679 Lot 25KBE552 DYNJ900004J UDI-DI 10198459560354 Lot 26AMA112 DYNJ901779J UDI-DI 10193489979749 Lot 25LMI890 DYNJ902900F UDI-DI 10198459496936 Lot 25KBA607 DYNJ81419D UDI-DI 10198459113444 Lot 25KBM670 DYNJ40498B UDI-DI 10193489806779 Lots 25KBC776 25LBO494 DYNJ901246J UDI-DI 10198459447310 Lots 25KBQ989 26ABI798 26DBH373 DYNJ909252C UDI-DI 10198459318726 Lots 25JBS227 25KBC598 25LBR040 DYNJ909255C UDI-DI 10198459210167 Lot 25LBH411 DYNJ905364B UDI-DI 10198459346255 Lots 25LBM363 26BBO336 CDS983347S UDI-DI 10198459397370 Lots 26BBC029 26CBR342 DYNJ89581 UDI-DI 10198459278594 Lot 25LBP819 DYNJT4872 UDI-DI 10198459459672 Lot 25KBA908 DYNJ38985G UDI-DI 10195327385682 Lots 25JBA164 25KBG575 DYNJ45706B UDI-DI 10193489856293 Lot 25KBK200 DYNJ905642F UDI-DI 10195327587277 Lot 26AME607 DYNJ81389F UDI-DI 10198459394775 Lot 26BBC753 DYNJ43700B UDI-DI 10195327523039 Lot 25LBD750 DYNJ0780036W UDI-DI 10198459036972 Lot 25LMJ600 CDS983693I UDI-DI 10193489953848 Lot 25KBQ399 CDS982720S UDI-DI 10198459530258 Lots 25KBU081 25LBT481 26ABC446 DYNJ66231B UDI-DI 10195327341640 Lots 25JBY408 25KBK197 DYNJ62820D UDI-DI 10198459105463 Lot 25LMH554 DYNJ89028A UDI-DI 10198459472565 Lot 25KBI158 DYNJ907206G UDI-DI 10198459368028 Lot 25LBM564
UPC codes
10198459440366, 10198459434679, 10198459560354, 10193489979749, 10198459496936, 10198459113444, 10193489806779, 10198459447310, 10198459318726, 10198459210167, 10198459346255, 10198459397370, 10198459278594, 10198459459672, 10195327385682, 10193489856293, 10195327587277, 10198459394775, 10195327523039, 10198459036972

Products covered by this recall

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

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459440366
  • 10198459434679
  • 10198459560354
  • 10193489979749
  • 10198459496936
  • 10198459113444
  • 10193489806779
  • 10198459447310
  • 10198459318726
  • 10198459210167
  • 10198459346255
  • 10198459397370
  • 10198459278594
  • 10198459459672
  • 10195327385682
  • 10193489856293
  • 10195327587277
  • 10198459394775
  • 10195327523039
  • 10198459036972

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 654 kits t

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459440366, 10198459434679, 10198459560354; lot code 654 kits t. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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