Medline Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA clearance. The recall affects 270,311 units distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving unapproved design changes to medical devices. The source text does not report any illnesses, injuries, or deaths, and the hazard is regulatory non-compliance rather than an acute safety threat. Under the rubric, Class II recalls without hospitalization reports typically score 2.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes, specifically the Face/Rhinoplasty Pack (DYNJ80343C) and Plastic Head-Neck Pack (DYNJ86639). The reason for the recall is that unapproved design changes were made to the products outside of the 510(k) clearance granted by the FDA.
The affected kits total 270,311 units and have been distributed worldwide, including US Nationwide distribution as well as shipments to Canada, Panama, and Barbados. The affected lot numbers are 24ABO127 (DYNJ80343C) and 24FBM972 (DYNJ86639).
Customers who have received these kits should stop using them and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- regulatory-non-compliance
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27