The Recall Desk
HighFDA (Devices)·Z-1451-2025·Announced 2025-04-02

Medline Procedure Kits with Defective Plastic Syringes Recalled for Safety

Medline is recalling medical procedure kits containing plastic syringes with quality defects including leaks and breakage that may pose a risk to patient health. The recall affects 5,132 units 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 medical device recall with identified physical defects (leaks and breakage) in surgical supplies that may pose a risk to patient health. No illnesses or injuries have been reported, placing this in the category of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling medical procedure kits used for ophthalmology and eye procedures. The kits contain plastic syringes affected by a defect identified in an FDA Safety Alert issued on March 19, 2024.

The syringes exhibit leaks, breakage, and other quality issues that may pose a risk to patient health. These defects could potentially compromise the integrity and safe use of the medical supplies.

The recall affects 5,132 units of procedure kits distributed nationwide in the United States and in Canada. The affected kits are identified by specific pack numbers and lot numbers listed in the FDA recall notice.

Healthcare facilities using these kits should identify and isolate affected stock based on the pack and lot numbers provided in the FDA recall notice. Contact Medline Industries or the FDA for additional information.

The recalled product

Product
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • syringe-leak
  • syringe-breakage
  • product-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 DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case)
  • Lot Number 23LMF853A
  • 2) Pack Number DYNJ39921B: UDI/DI 10195327176365 (each) 40195327176366 (case)
  • Lot Number 24AMI654A
  • 3) Pack Number DYNJ45662C: UDI/DI 10193489556636 (each) 40193489556637 (case)
  • Lot Number 20EBE340A
  • 4) Pack Number DYNJ56056B: UDI/DI 10193489635348 (each) 40193489635349 (case)
  • Lot Number 20JKA823A
  • 5) Pack Number DYNJ56553B: UDI/DI 10193489761962 (each) 40193489761963 (case)
  • Lot Number 21IMG706A
  • 6) Pack Number DYNJ0417156G: UDI/DI 10889942067428 (each) 40889942067429 (case)
  • Lot Number 22IMG784A
  • 7) Pack Number DYNJ60411A: UDI/DI 10195327221393 (each) 40195327221394 (case)
  • Lot Number 22IMG811A
  • 8) Pack Number DYNJ52649F: UDI/DI 10195327357313 (each) 40195327357314 (case)
  • Lot Number 23HME435A
  • 9) Pack Number DYNJVB1076B: UDI/DI 10195327062736 (each) 40195327062737 (case)
  • Lot Number 23CLA046A
  • Lot Number 22IMD667A
  • 11) Pack Number DYNJ40081F: UDI/DI 10195327068370 (each) 40195327068371 (case)

Distribution

Distributed nationwide across the United States.

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