FDA Device recall Z-2252-2025
HVI CARDIAC ROBOT PACK. Medical convenience kit
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of HVI CARDIAC ROBOT PACK. Medical convenience kit by Avid Medical, citing CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2252-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | CA, IL, MD, OH, PA, TX, WA |
Product
HVI CARDIAC ROBOT PACK. Medical convenience kit.
Reason
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Identifiers
| code_info | Model No. RYCB72-04; UDI: 10809160434666; Kit Lot No. 1625487. |
|---|
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-2252-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.