Bubble Sensor — Class II medical device recall Z-1053-2024
Ongoing recall by Maquet Medical Systems USA, reported 2024-02-14, distributed in AZ, CA, CO, FL, GA, IA, IL, MN…. The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorr
| Recall number | Z-1053-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Distributed | AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA, WI |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04037691816432, 04058863025148 |
| Model numbers | 3/8X3/32, 70105.5720, L1.7 |
Product
Bubble Sensor (REF: 70105.5720)
Reason for recall
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
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-1053-2024. 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.