FDA DevicesClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Published: April 29, 2026Recall ID: Z-1888-2026Category: devicesCountry: US
Reason for Recall / Hazard
Unapproved design changes to the products outside of the 510(k) clearance.
Product Description & Identification
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Affected Products
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98601 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811 |
| Postal code | 60093-2753 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 270,311 total |
| Reason for recall | Unapproved design changes to the products outside of the 510(k) clearance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.