Z-1938-2024 Class II Ongoing
FDA device recall Z-1938-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 22, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 5,075,234 syringes.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2024
- Initiation Date
- Apr 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,075,234 syringes
Product Description
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Code Information
UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1938-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026