The Recall Desk
HighFDA (Devices)·Z-2504-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C;

Pending LLM rewrite. Source: FDA_DEVICE Z-2504-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

The recalled product

Product
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
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 (10)

  • Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each)
  • 40195327008865 (case)
  • Lot Number 21KME435
  • Lot Number 21JMC247
  • Lot Number 21JMB678
  • Lot Number 21IMH919
  • Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each)
  • 40195327605583 (case)
  • Lot Number 24CBO389
  • Lot Number 24ABR872.

Distribution

Distributed nationwide across the United States.

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