Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall of medical procedure kits containing defective plastic syringes. FDA Class I recalls meet the Critical severity threshold per the rubric. While no illnesses or deaths have been reported, the defects in syringes used in medical procedures pose a recognized risk to patient safety.
Plain-English summary
Medline Industries, LP is recalling approximately 1.6 million medical procedure kits affected by defective plastic syringes. The recalled kits are available in multiple types, including continuous block, combined spinal and epidural, universal block tray, basic diagnostic tray, preop nerve block tray, pain tray, continuous epidural, and 20G single dose epidural formats, with specific pack numbers and lot numbers identified in the recall.
The plastic syringes in these kits are covered by an FDA Safety Alert issued on March 19, 2024. The syringes have leaks, breakage, and other quality issues that may pose a risk to patient health.
Distribution of the recalled kits extends to the United States and multiple countries worldwide. Healthcare facilities and patients who have received these kits should check their pack numbers and lot numbers against the official recall list to determine if their products are affected.
The recalled product
- Product
- Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- defect
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)
- DYNJRA0960C
- Lot Number 23CBH823
- Lot Number 23EBC905
- Lot Number 23EBV028
- Lot Number 23HBO071
- Lot Number 24BBI322
- DYNJRA1268C
- Lot Number 22GLB081
- Lot Number 22HLA566
- Lot Number 22ILA092
- Lot Number 22LLA800
- Lot Number 23DLA368
- Lot Number 23FLA942
- Lot Number 23GLA321
- Lot Number 23HLA910
- Lot Number 23ILA593
- DYNJRA1638C
- Lot Number 23EBA854
- Lot Number 23GBE493
- Lot Number 23KBJ159
Distribution
Distributed nationwide across the United States.
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