Z-1938-2024Class II

Medline Luer Slip Disposable Syringe without Needle, Ref Syr101020

Name: Z-1938-2024 Medline Luer Slip Disposable Syringe without Needle, Ref Syr101020
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-04-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-22 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 on 2024-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1938-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-22
Posted: 2024-05-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Luer Slip Disposable Syringe without Needle, Ref Syr101020
Product code: FMF Syringe, Piston
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.
FDA 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 in commerce: 5,075,234 syringes
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Product codes and lots: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1938-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1937-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31
Z-1938-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-05-31

Product code FMF

K061275Class IIMedline Syringes, MultipleMedline Industries, Inc. / cleared 2006-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)