The Recall Desk
HighFDA (Devices)·Z-2501-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2

Pending LLM rewrite. Source: FDA_DEVICE Z-2501-2026.

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) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIV
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 (20)

  • Medline Kit Number/SKU DYNJ47625B
  • UDI/DI 10889942182589 (each)
  • 40889942182580 (case)
  • Lot Number 21LBI584
  • Medline Kit Number/SKU DYNJ912219
  • UDI/DI 10198459676048 (each)
  • 40198459676049 (case)
  • Lot Number 26BBQ085
  • Medline Kit Number/SKU DYNJ907033B
  • UDI/DI 10195327205980 (each)
  • 40195327205981 (case)
  • Lot Number 23BBK437
  • Lot Number 22LBP927
  • Lot Number 22KBA970
  • Lot Number 22JBH943
  • Lot Number 22HBR879
  • Medline Kit Number/SKU DYNJ68663B
  • UDI/DI 10195327408886 (each)
  • 40195327408887 (case)
  • Lot Number 25ABD038

Distribution

Distributed nationwide across the United States.

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