FDA Device recall Z-1300-2026
Bubble Sensor for 3/8" x 3/32" tubing
- FDA Device
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Bubble Sensor for 3/8" x 3/32" tubing by Maquet Cardiopulmonary, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-09 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Maquet Cardiopulmonary |
| Distribution | US |
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Reason
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.
Identifiers
| code_info | Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2026%22
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