The Recall Desk
HighFDA (Devices)·Z-1441-2025·Announced 2025-04-02

Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage

Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in 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: FDA Class II recall with identified syringe leakage and breakage issues that may pose risks during surgical use. No illnesses or injuries have been reported, but the defects in surgical instruments carry potential for patient harm.

Plain-English summary

Medline Industries, LP has recalled 11,774 surgical procedure kits distributed nationwide in the United States and to Canada. The kits include multiple variants used in various surgical procedures, including laparoscopic cholecystectomy, ablation, and specialized surgical packs.

The recalled kits contain plastic syringes that were affected by an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified in these syringes, which may pose a risk to patient health.

Each recalled kit has specific pack numbers and lot codes that are listed in the detailed FDA recall notice. Healthcare facilities should reference these identifiers to determine if they have received affected products.

The recalled product

Product
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Supply Kit
Hazard
  • syringe-leakage
  • syringe-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 DYNJ40629B: UDI/DI 10888277778696 (each) 40888277778697 (case)
  • Lot number 21EME542A
  • 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case)
  • Lot number 21LBH976A
  • 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case)
  • Lot number 22GBX458A
  • 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case)
  • Lot number 23LMF912A
  • 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case)
  • Lot number 22GBI566A
  • 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case)
  • Lot number 23HMC076A
  • 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case)
  • Lot number 23EMC403A
  • 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case)
  • Lot number 23HMC803A
  • 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case)
  • Lot number 21JMH176A
  • 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case)
  • Lot number 22GBH503A

Distribution

Distributed nationwide across the United States.

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