Medline Medical Procedural Kits Recalled for Defective Plastic Syringes
Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.
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 classified as FDA Class II and involves medical devices where quality defects (leakage and breakage) may pose a risk to patient health during surgical and medical procedures. No illnesses or injuries have been reported, placing this in the High category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple procedural kits distributed worldwide due to defective plastic syringes. The recalled kits are affected by manufacturing quality issues that may cause leakage or breakage during use.
The affected products include: GLMI Arthrogram Kit (Pack Number SPEC0300B), Mercy Medical Circumcision Tray (Pack Number CIT6780), Nursery Circumcision Tray (Pack Number CIT4845), Peripheral Ultrasound Catheter Insertion Kit (Pack Number MNS9865), and Sterile 1CC Syringe with 25G Needle (Pack Number DYNDA2497). The syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024.
These quality defects may pose a risk to patient health. Healthcare facilities and medical practitioners worldwide should be aware of this recall and verify whether they have received any of the affected kits.
The recalled product
- Product
- Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERI
- 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 (11)
- SPEC0300B
- Lot Number 2022033050
- CIT6780
- Lot Number 2022042550
- CIT4845
- Lot Number 2022032450
- MNS9865
- Lot Number 2022021850
- Lot Number 2022041850
- DYNDA2497
- Lot Number 2022042650
Distribution
Distribution scope not specified by the agency.
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