The Recall Desk
HighFDA (Devices)·Z-1444-2025·Announced 2025-04-02

Medline surgical procedure kits recalled for syringe leaks and breakage

Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.

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 FDA Class II recall involves identified quality issues (leaks, breakage) in sterile surgical equipment that pose a potential risk to patient health. Since no illnesses or injuries have been reported, this meets the criterion for 'High' severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling 11,363 units of sterile surgical procedure kits containing plastic syringes. The affected kits include 84 different product varieties, labeled under names such as A & A Knee Pack, ABD Closure Pack, Adult Perc Pack, and Basic Pack, among others.

The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks and breakage have been identified that may pose a risk to patient health.

These procedure kits have been distributed nationwide in the United States and in Canada. Healthcare facilities using these products should verify their inventory against the specific pack numbers and lot numbers listed in the FDA recall notice.

The recalled product

Product
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedure kits
Hazard
  • leakage
  • breakage
  • quality-defect

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 DYNJHS0136D: UDI/DI 10889942848973 (each) 40889942848974 (case)
  • Lot Number 22JBC557Z
  • 2) Pack Number DYNJ56987B: UDI/DI 10889942868193 (each) 40889942868194 (case)
  • Lot Number 21EBN072A
  • Lot Number 21IMG402A
  • 4) Pack Number DYNJ54836B: UDI/DI 10193489574128 (each) 40193489574129 (case)
  • Lot Number 21BBH689A
  • 5) Pack Number DYNJ58678A: UDI/DI 10888277781207 (each) 40888277781208 (case)
  • Lot Number 21GMF677A
  • 6) Pack Number DYNJ63532: UDI/DI 10193489748468 (each) 40193489748469 (case)
  • Lot Number 22CMB574A
  • 7) Pack Number DYNJ81702: UDI/DI 10195327135447 (each) 40195327135448 (case)
  • Lot Number 23CBF695A
  • 8) Pack Number DYNJ36595D: UDI/DI 10193489928976 (each) 40193489928977 (case)
  • Lot Number 23CBL653A
  • 9) Pack Number DYNJ69250A: UDI/DI 10195327142315 (each) 40195327142316 (case)
  • Lot Number 23HME051A
  • 10) Pack Number DYNJ50470C: UDI/DI 10889942922611 (each) 40889942922612 (case)
  • Lot Number 23FME520A
  • Lot Number 23FME450A

Distribution

Distributed nationwide across the United States.

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