Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 29, 2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, pre…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Usa Sales Inc recalled Flow-c Anesthesia System : intended for use in administering anesthesia while controllin… - a critical-severity action.
Flow-c Anesthesia System : intended for use in administering anesthesia while controllin… was recalled by Getinge Usa Sales Inc in June 29, 2022. Reason: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable ris…. Check the official notice for the remedy. Verify recall #Z-1278-2022 with the FDA Devices before acting.
The recall
Getinge Usa Sales Inc issued this critical-severity FDA Devices recall-Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable ris….
- Critical
- severity level
- 17 units
- affected scope
- Class I
- classification
- June 29, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1278-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1278-2022) was formally reported on June 29, 2022, with the manufacturer initiating the action on May 2, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Getinge Usa Sales Inc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 17 units US.
The documented reason for this recall is: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being acti… Distribution data in the federal record shows the product reached: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia. 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
17 units US
Related Recalls
6
3 from same agency
Product description
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Reason for recall
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1278-2022 |
| Date reported | June 29, 2022 |
| Date initiated | May 2, 2022 |
| Recalling firm | Getinge Usa Sales Inc |
| Firm location | Wayne, NJ |
| Affected scope | 17 units US |
| Distribution | US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia |
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-1278-2022) 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-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700. Recalled by Getinge Usa Sales Inc. Units affected: 17 units US.
Why was this product recalled? ▼
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2022. Severity: Critical. Recall number: Z-1278-2022.
Where was the recalled product distributed? ▼
Distribution: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1278-2022) 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 29, 2022. 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.