Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.
What this means for you
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: This is an FDA Class II recall of medical devices with identified quality defects (leaks and breakage) in plastic syringes used in medical procedures. The source reports no illnesses or injuries to date. Per the rubric, risk-of-harm medical devices with identified defects but no reported harm score as High (3).
Plain-English summary
Medline Industries, LP has recalled multiple medical convenience kits that contain plastic syringes. These kits are used in surgical procedures including angiography, neurosurgery, and ventriculoperitoneal shunt placement.
The recall was prompted by an FDA Safety Alert issued on March 19, 2024, regarding quality issues identified in the plastic syringes. The defects, including leaks, breakage, and other quality problems, may pose a risk to patient health.
The affected kits have been distributed worldwide to healthcare facilities and surgical centers. The recall encompasses numerous product pack numbers and lot numbers manufactured by Medline Industries, LP.
Healthcare providers using these kits should cease use of affected lots and verify whether their inventory includes recalled products using the provided lot and pack number information.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-breakage
- device-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)
- 00-401327AA
- Lot Number 20AMA256
- Lot Number 20AMC142
- Lot Number 20BMB258
- Lot Number 20DMB109
- Lot Number 20GMB772
- Lot Number 20HMC035
- Lot Number 20JMA910
- Lot Number 20JMB656
- Lot Number 21CMA167
- Lot Number 21EMB860
- Lot Number 21FMC472
- Lot Number 21GMF286
- Lot Number 21HME693
- Lot Number 21IMC842
- Lot Number 21KMB315
- 00-401594R
- Lot Number 19LDA473
- Lot Number 20ADB972
- Lot Number 20CDC521
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03