The Recall Desk
HighFDA (Devices)·Z-0756-2025·Announced 2025-01-01

Medline Surgical Needle Holders Recalled for Sterility Compromise

Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.

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 recall involving surgical equipment with weak seals that compromise sterility. Although no illnesses or injuries have been reported, the hazard presents a clear risk of contamination and infection. Per the severity rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

Medline Industries is recalling the ST OR MAYO HEGAR NEEDLEHOLDER 6" (Item No. 67870, Lot 2023091290) due to weak seals that may compromise product sterility. The product is a surgical instrument used in operating room procedures.

When the seal breaches, it may not be detectable to the user. This defect creates a risk of contamination and infection during or after surgical procedures where the instrument is used.

The affected product was distributed nationwide throughout the United States. Approximately 21,440 units are involved in this recall, identified by UDI 00653160196894 (individual unit) and 30653160196895 (case).

The recalled product

Product
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Instruments
Hazard
  • sterility-breach
  • contamination-risk

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: 00653160196894 (ea) 30653160196895 (case)
  • Lot 2023091290

Distribution

Distributed nationwide across the United States.

Related recalls

Same category