Medline Convenience Kits with Polycarbonate Syringes 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 510(k) clearance.
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: FDA Class II recall for unapproved design changes. No reported injuries or illnesses are documented in the source text, and the hazard is regulatory non-compliance rather than an identified safety defect, placing this in the Moderate category.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes (Arthroscopy Pack, model DYNJ45173D). The products have undergone design changes that were not approved through the FDA 510(k) clearance process.
The affected products have been distributed worldwide, including nationwide in the United States and internationally in Canada, Panama, and Barbados. The recall involves lot 24BBB811 with a total of 270,311 units.
Patients and healthcare providers who have these products should stop using them and contact Medline Industries for instructions on return or replacement. Healthcare facilities should verify whether they have received affected units and quarantine them pending further guidance.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringes
- Hazard
- unapproved-design-change
- regulatory-non-compliance
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 (1)
- DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
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