The Recall Desk
HighFDA (Devices)·Z-1445-2025·Announced 2025-04-02

Medline Laceration Tray Procedure Kits Recalled for Syringe Defects

Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential 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: FDA Class II medical device recall for plastic syringes with quality defects (leaks, breakage) that may pose patient health risks. No reported illnesses or injuries, making this a theoretical risk-of-harm scenario.

Plain-English summary

Medline Industries is recalling Laceration Tray procedure kits (Pack Number DYNJ17328B, Lot 21LBA554A). The kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recall involves 108 units distributed worldwide, including throughout the United States and Canada.

The plastic syringes in these kits have been identified with quality issues including leaks, breakage, and other defects. These defects may pose a risk to patient health.

The recalled product

Product
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedure Kit
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 (2)

  • 1) Pack Number DYNJ17328B: UDI/DI 10080196232895 (each) 40080196232896 (case)
  • Lot Number 21LBA554A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category