FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
- Recall number
- Z-1937-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
- Status
- Open, Classified
- Initiated
- 2024-04-22
- Posted
- 2024-05-31
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 25,214,334 syringes
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
- Lot, serial or model codes
- UDI/DI 10884389596319, All lots in the format: 897YYMMXXXX
- 510(k) numbers
- ["K061275"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28