Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 11, 2026
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
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…
Maquet Cardiopulmonary Gmbh recalled Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; - a moderate-severity action.
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; was recalled by Maquet Cardiopulmonary Gmbh in February 11, 2026. Reason: Internal investigations have identified an issue with the durability of the connecting cable near the connect…. Check the official notice for the remedy. Verify recall #Z-1300-2026 with the FDA Devices before acting.
The recall
Maquet Cardiopulmonary Gmbh issued this moderate-severity FDA Devices recall-Internal investigations have identified an issue with the durability of the connecting cable near the connect….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- February 11, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1300-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1300-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on January 9, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Maquet Cardiopulmonary Gmbh is listed as the recalling firm, operating out of Rastatt, N/A. Federal records list the affected scope as 3050 units.
The documented reason for this recall is: 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 Veno… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3050 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1300-2026 |
| Date reported | February 11, 2026 |
| Date initiated | January 9, 2026 |
| Recalling firm | Maquet Cardiopulmonary Gmbh |
| Firm location | Rastatt, N/A |
| Affected scope | 3050 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colo… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1300-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;. Recalled by Maquet Cardiopulmonary Gmbh. Units affected: 3050 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1300-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1300-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 11, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.