Data Foundry

Medical device recalls 2025

20/30 Priority Pack Accessory Kit w/Copilot — Class II medical device recall Z-0732-2025

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 numberZ-0732-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAbbott Vascular Inc, Temecula, CA, United States
Recall initiated2024-11-06
Classified2024-12-20
Reported by FDA2025-01-01
DistributedAL, 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
Quantity23,407
Reason classespackaging
UPC / GTIN / UDI-DI08717648013973
Lot numbers60516923, 60553232, 60553233, 60556003, 60556008, 60556009, 60556011, 60556012, 60556014, 60557297, 60559370, 60559371, 60559374, 60559375, 60559376, 60561751, 60561752, 60561753, 60561754, 60561755
Model numbers1003327

Product

20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

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-0732-2025. 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.