The Recall Desk
HighFDA (Devices)·Z-2503-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEA

Pending LLM rewrite. Source: FDA_DEVICE Z-2503-2026.

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 BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
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 DYNJ905924B: UDI/DI 10193489773484 (each)
  • 40193489773485 (case)
  • Lot Number 24GMJ742
  • Lot Number 24FMC978
  • Lot Number 24CMA556
  • Lot Number 24BMI027
  • Lot Number 24AMF247
  • Lot Number 24AMA807
  • Lot Number 23IMF051
  • Lot Number 23HMG141
  • Lot Number 23EMF259
  • Lot Number 23DMA689
  • Lot Number 23CMF097
  • Lot Number 23CMC699
  • Lot Number 22LME333
  • Lot Number 22KMB390
  • Lot Number 22HMC449
  • Lot Number 22GMD678
  • Lot Number 22FMG214
  • Lot Number 22DME100

Distribution

Distributed nationwide across the United States.

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