The Recall Desk
HighFDA (Devices)·Z-1446-2025·Announced 2025-04-02

Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes

Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.

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: This is an FDA Class II recall of medical devices used in critical obstetric procedures. While the defective syringes may pose a risk to patient health, no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without documented injury warrant a High rating.

Plain-English summary

Medline Industries is recalling 1,958 units of delivery and labor procedure kits distributed nationwide in the United States and Canada. The kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.

Leaks, breakage, and other quality issues have been identified in the affected syringes. These defects may pose a risk to patient health during obstetric procedures.

The recalled kits include various models identified by pack numbers and lot numbers, distributed as convenience kits for labor and delivery use in healthcare settings.

The recalled product

Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Obstetric/Labor Delivery Kits
Hazard
  • syringe-leak
  • syringe-breakage

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)

  • 1) Pack Number DYNJ0923016: UDI/DI 10889942099634 (each) 40889942099635 (case)
  • Lot Number 23IMF426A
  • 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case)
  • Lot Number 21JMG530A
  • 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case)
  • Lot Number 21IMH700A
  • 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case)
  • Lot Number 22IBG256Z
  • 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case)
  • Lot Number 23HMC532A
  • 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case)
  • Lot Number 22CMB444A
  • 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case)
  • Lot Number 23IMF243A
  • 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case)
  • Lot Number 22JMB827A
  • 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case)
  • Lot Number 22LBE104A
  • 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case)
  • Lot Number 21EBN038A

Distribution

Distributed nationwide across the United States.

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