Class II U.S. Food and Drug Administration

Medline convenience kit: BHS Neuro Dynj904900N Medtrx Neuro Pack 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-2428-2026
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
DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
UPC codes
10198459504273, 10198459084331, 10195327587291, 10198459224577, 10198459495427, 10198459620225, 10198459449550, 10195327105020, 10198459553660, 10198459487149, 10195327007249

Products covered by this recall

Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

Check your product

The notice names 13 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.

  • 10198459504273
  • 10198459084331
  • 10195327587291
  • 10198459224577
  • 10198459495427
  • 10198459620225
  • 10198459449550
  • 10195327105020
  • 10198459553660
  • 10198459487149
  • 10195327007249

Lot or batch code

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

  • 25LBE309 — 49
  • 654 kits total

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 the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

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 10198459504273, 10198459084331, 10195327587291; lot code 25LBE309 — 49, 654 kits total. 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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