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

Medline labour delivery and vaginal kits contain substandard catheters

Medline labour and delivery and vaginal procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 24,388 units affected.

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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.

Plain-English summary

Medline Industries, LP is recalling medical procedure kits labeled as BR L&D Pack (DYNJ47625B), GYN Vaginal (DYNJ912219), Kit Maj Vag Set Up (DYNJ907033B) and Minor Vag Pack, among the products listed in the recall notice. The action covers 24,388 units.

During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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 FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.

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 — Surgical procedure kit
Hazard
Affected units
24,388

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · out of specification

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