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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 21,440
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.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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