Bubble Sensor for 3/8" x 3/32" tubing — Class II medical device recall Z-1300-2026
Ongoing recall by Maquet Cardiopulmonary Gmbh, reported 2026-02-11, distributed nationwide. Internal investigations have identified an issue with the durability of the connecting cable near the connecti
| Recall number | Z-1300-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiopulmonary Gmbh, Rastatt, N/A, Germany |
| Recall initiated | 2026-01-09 |
| Classified | 2026-02-05 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KR, LT, LV, MA, MX, NI, NL, NO, NZ, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 3,050 units |
| UPC / GTIN / UDI-DI | 04037691816432 |
| Model numbers | 701055720 |
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Reason for recall
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
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-1300-2026. 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.