The Recall Desk
HighFDA (Devices)·Z-1465-2025·Announced 2025-04-02

Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk

Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units 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 is an FDA Class II recall of surgical procedure kits with plastic syringes subject to quality defects (leaks and breakage). Per the rubric, this qualifies as a risk-of-harm product where no injuries are reported, scoring as High severity.

Plain-English summary

Medline Industries is recalling multiple medical procedure kits that contain plastic syringes affected by quality issues identified in an FDA Safety Alert issued on March 19, 2024. These kits are used in various surgical and orthopedic procedures.

The plastic syringes in these kits are subject to leaks, breakage, and other quality defects that may compromise the sterility and functionality of the kits during medical procedures, potentially posing a risk to patient health.

Approximately 14,589 units of affected procedure kits have been distributed to healthcare facilities nationwide in the United States and Canada.

The recalled product

Product
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • syringe-leak
  • 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 DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case)
  • Lot Number 20BDA583A
  • 2) Pack Number DYNJ64332: UDI/DI 10889942692262 (each) 40889942692263 (case)
  • Lot Number 20BDB394A
  • 3) Pack Number DYNJ38748F: UDI/DI 10193489275063 (each) 40193489275064 (case)
  • Lot Number 20BDB587A
  • 4) Pack Number DYNJ38748F: UDI/DI 10889942524334 (each) 40889942524335 (case)
  • Lot Number 20BDB606A
  • 5) Pack Number DYNJ65817: UDI/DI 10193489744910 (each) 40193489744911 (case)
  • Lot Number 20EBL095A
  • 6) Pack Number DYNDH1937: UDI/DI 10193489773088 (each) 40193489773089 (case)
  • Lot Number 20FBS286Z
  • 7) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case)
  • Lot Number 20FBS559A
  • 8) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case)
  • Lot Number 20FMA565A
  • 9) Pack Number DYNJ38716C: UDI/DI 10193489706796 (each) 40193489706797 (case)
  • Lot Number 20GBA802Z
  • 10) Pack Number DYNJ33639J: UDI/DI 10193489783247 (each) 40193489783248 (case)
  • Lot Number 20GKA136A

Distribution

Distributed nationwide across the United States.

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