CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
ST OR Mayo Hegar Needleholder 6"(OR2500), Medline recalled
Medline Industries LP - Northfield is recalling ST OR Mayo Hegar Needleholder 6"(OR2500), Medline, distributed nationwide in the US. The recall was initiated on 12 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0756-2025
- FDA event ID
- 95843
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2024
- FDA classified
- 23 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 12 Nov 2024 | Recall initiated by company | |
| 23 Dec 2024 | Classified by FDA | +41 days |
| 1 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Which lots are affected?
UDI: 00653160196894 (ea) 30653160196895 (case); Lot 2023091290
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 95843This product is part of a recall event; the main page for the event is ST Reprocessed Bruns Curette #00 (BC00), Medline recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ST Reprocessed Bruns Curette #00 (BC00), Medline recalled | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile Magill Forcep (MAGF9), Medline recalled | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | O.R. Scissors, S/B, 5.5 Sterile, Medline recalled | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Rummell, Medline recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile Strt Kelly Hemostat (SK8039S), Medline recalled | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | ST IUD Removal Hook 10" (504090), Medline recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |