Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010

FDA Recall Z-1937-2024 · Posted 2024-05-31

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFMF
Date Initiated2024-04-22
Product Quantity25,214,334 syringes

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061275MEDLINE SYRINGES, MULTIPLEMedline Industries, Inc. · 2006-07-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑