Medline Luer Lock Disposable Syringe Without Needle, Ref… recallZ-1937-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline Industries, LP, issued a recall notice to its consignees on 04/22/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested that the affected product be destroyed.
Recall details
- Recall number
- Z-1937-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2024
- Posted by the FDA
- May 31, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 25,214,334 syringes
- Product code
- FMF
- FDA submissions
- K061275
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Product description
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Code information (models, lots, serial numbers)
UDI/DI 10884389596319, All lots in the format: 897YYMMXXXX
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline SYR101010Medline Industries, Inc. · Syringe, piston1 recall12 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94537).
- Z-1938-2024 · Open, ClassifiedMEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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