FDA DevicesClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Published: April 29, 2026Recall ID: Z-1889-2026Category: 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 E P DRAPE PACK-LF DYNJ0373061J
Affected Products
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98601 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895 |
| 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.