Class II U.S. Food and Drug Administration

Medline medical procedure convenience kits labeled as: 1) Pacer / Cath recall: Medline kits were manufactured and distributed containing MASTISOL liquid

Recall published 9 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

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-1188-2026
Published
February 4, 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
1,928 total
Distribution
Nationwide
Made in
United States
Lot / code info
Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144; Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419; Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793; Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988; Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161; Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211; Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489; Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551.
UPC codes
10889942403905, 40889942403906, 10198459385582, 40198459385583, 10193489494983, 40193489494984, 10198459514579, 40198459514570, 10198459017018, 40198459017019, 10198459478505, 40198459478506, 10193489931822, 40193489931823, 10198459260452, 40198459260453

Products covered by this recall

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.

Check your product

The notice names 33 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.

  • 10889942403905
  • 40889942403906
  • 10198459385582
  • 40198459385583
  • 10193489494983
  • 40193489494984
  • 10198459514579
  • 40198459514570
  • 10198459017018
  • 40198459017019
  • 10198459478505
  • 40198459478506
  • 10193489931822
  • 40193489931823
  • 10198459260452
  • 40198459260453

Lot or batch code

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

  • 25KMD144
  • 25KMD419
  • 25KMD793
  • 25KMI988
  • 25KMH161
  • 25LMB211
  • 25KMJ489
  • 25KDB551. — 1
  • 928 total

Model or item number

On the rating label, the box or the instruction sheet.

  • DYNJ0972604A
  • DYNJ33822L
  • DYNJ45640B
  • DYNJ63377D
  • DYNJ65011D
  • DYNJ69143C
  • DYNJ69313
  • DYNJ86007B

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889942403905, 40889942403906, 10198459385582; lot code 25KMD144, 25KMD419, 25KMD793; model number DYNJ0972604A, DYNJ33822L, DYNJ45640B. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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