The Recall Desk
HighFDA (Devices)·Z-1449-2025·Announced 2025-04-02

Medline Procedure Kits With Defective Syringes Recalled Nationwide

Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.

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 involving surgical procedure kits with defective syringes. Although no illnesses or hospitalizations are reported, the defects (leaks, breakage) in syringes used during procedures represent a documented risk to patient health.

Plain-English summary

Medline Industries, LP is recalling five models of medical procedure kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits are used for abdominal hysterectomy, vaginal hysterectomy, and robotic-assisted laparoscopic procedures.

The recalled syringes may leak, break, or have other quality issues that could compromise their integrity during use. These defects may pose a risk to patient health during medical procedures.

The recall affects 268 units distributed nationwide in the United States and Canada. Affected kits are identified by specific pack numbers and lot numbers, as documented by the FDA.

Healthcare facilities and providers who have received these kits should contact Medline Industries immediately for replacement or instructions. Patients who have concerns about procedures performed with these kits should consult their healthcare provider.

The recalled product

Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • syringe-leakage
  • 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 (10)

  • 1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case)
  • Lot Number 23JBW085A
  • 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case)
  • Lot Number 22CDB491A
  • 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case)
  • Lot Number 21IBP928Z
  • 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case)
  • Lot Number 21GMA889A
  • 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case)
  • Lot Number 23EMD924A

Distribution

Distributed nationwide across the United States.

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