The Recall Desk
HighFDA (Devices)·Z-1454-2024·Announced 2024-04-10

Medline wire cut scissors may have weak seal compromising sterility

Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.

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 a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is a potential sterility breach on surgical instruments, which represents a risk-of-harm to patients but has not resulted in documented patient harm. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3.

Plain-English summary

Medline Industries is recalling 800 units of its 4.5-inch wire cut scissors (Product Code DYND04006, Lot Number 2023031390) because the product may have a weak seal that could result in a breach of sterility if the seal fails.

According to the manufacturer, the weak seal is not easily detectable by all users, meaning affected products could potentially be used without awareness that sterility has been compromised. For surgical instruments, loss of sterility could pose a risk during medical procedures.

The affected scissors were distributed worldwide, including throughout the United States, Panama, and Canada. Users who have received this product should stop using it and contact Medline Industries for instructions regarding replacement or proper handling.

The recalled product

Product
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • weak-seal
  • sterility-compromise

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 (2)

  • UDI/DI 40884389097350 (case) 10884389097359 (each)
  • Lot Numbers: 2023031390

Distribution

Distributed nationwide across the United States.