20/30 Priority Pack Accessory Kit/ — Class II medical device recall Z-0731-2025
Ongoing recall by Abbott Vascular Inc, reported 2025-01-01, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or
| Recall number | Z-0731-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular Inc, Temecula, CA, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI |
| Quantity | 3,673 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08717648013614 |
| Lot numbers | 60538750, 60538751, 60539113, 60545329 |
| Model numbers | 1000186 |
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Reason for recall
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0731-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.