CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
Medline Luer Lock Disposable Syringe Without Needle recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Luer Lock Disposable Syringe Without Needle, distributed nationwide in the US. The recall was initiated on 22 Apr 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-1937-2024
- FDA event ID
- 94537
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2024
- FDA classified
- 31 May 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 22 Apr 2024 | Recall initiated by company | |
| 31 May 2024 | Classified by FDA | +39 days |
| 12 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Questions about this recall
Is Medline Luer Lock Disposable Syringe Without Needle recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Luer Lock Disposable Syringe Without Needle on 22 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-1937-2024.
Why was it recalled?
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Which lots are affected?
UDI/DI 10884389596319, All lots in the format: 897YYMMXXXX
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 |