Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 17, 2015
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventila…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Cardiovascular Us Sales, Llc recalled FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administerin… - a critical-severity action.
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administerin… was recalled by Maquet Cardiovascular Us Sales, Llc in June 17, 2015. Reason: In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage withi…. Check the official notice for the remedy. Verify recall #Z-1706-2015 with the FDA Devices before acting.
The recall
Maquet Cardiovascular Us Sales, Llc issued this critical-severity FDA Devices recall-In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage withi….
- Critical
- severity level
- Class I
- classification
- June 17, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1706-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1706-2015) was formally reported on June 17, 2015, with the manufacturer initiating the action on April 2, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Maquet Cardiovascular Us Sales, Llc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 1641 [80 units (US) 1561 units (OUS)].
The documented reason for this recall is: In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation. Distribution data in the federal record shows the product reached: Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colomb…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1641 [80 units (US) 1561 units (OUS)]
Related Recalls
6
3 from same agency
Product description
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Reason for recall
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1706-2015 |
| Date reported | June 17, 2015 |
| Date initiated | April 2, 2015 |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Firm location | Wayne, NJ |
| Affected scope | 1641 [80 units (US) 1561 units (OUS)] |
| Distribution | Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech R… |
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-1706-2015) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 1641 [80 units (US) 1561 units (OUS)].
Why was this product recalled? ▼
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Critical. Recall number: Z-1706-2015.
Where was the recalled product distributed? ▼
Distribution: Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1706-2015) 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 June 17, 2015. 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.