The Recall Desk
Severity pendingFDA (Devices)·Z-1188-2026·Announced 2026-02-04

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0

Pending LLM rewrite. Source: FDA_DEVICE Z-1188-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

Product
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, Ki
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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.

Distribution

Distributed nationwide across the United States.

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