FDA Device recall Z-0349-2025
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A by Medline Industries Northfield, citing products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0349-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-04 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Reason
Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Identifiers
| code_info | UDI-DI:10889942848447; Lot Number: 24EBP466 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0349-2025%22
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