Medline Syringes Recalled Due to Leaks, Breakage, and Quality Issues
Medline Industries is recalling over 2.3 million syringes due to identified leaks, breakage, and quality issues that may pose risks to patient health. The affected syringes were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical devices with identified functional defects (leaks and breakage) that may pose health risks. No injuries or illnesses are reported in the source, so this meets the rubric criterion for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling approximately 2,348,430 syringes of multiple models and sizes. The affected products are labeled with various control and low-pressure designations, including 3ML, 5ML, 10ML, and 20ML volumes, with specific item numbers and lot codes identified by the FDA.
The syringes were identified in an FDA Safety Alert issued March 19, 2024, due to leaks, breakage, and other quality issues. These defects may pose a risk to patient health and safety.
The affected syringes have been distributed worldwide, including throughout the United States, Canada, and Panama. Healthcare facilities and distributors that received affected products should immediately stop use and contact Medline Industries for guidance on returns or replacement.
Patients or healthcare providers who have concerns about syringes they have received should contact their healthcare provider or Medline Industries directly for information on proper handling and replacement options.
The recalled product
- Product
- Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,348,430
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Item Numbers: 1. DNSC91881
- GTIN 10884389730225
- Lot Numbers: 23KDA810
- 23KDA809
- 23KDA808
- 23JDB372
- 23JDB371
- 23JDB370
- 23FDB723
- 23FDB722
- 23FDB721
- 23EDC604
- 23EDC601
- 23EDC598
- 23DDA082
- 23CDA063
- 22LDB994
- 22JDB444
- 22JDB317
- 22GDA044
Distribution
Distributed nationwide across the United States.
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