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
- 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.
See all 7 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterility breach
See all →- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline IV Start Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Blood Draw and Phlebotomy Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09