Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 11, 2024
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this is…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mindray Ds USA, Inc. dba Mindray North America recalled Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to pro… - a moderate-severity action.
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to pro… was recalled by Mindray Ds USA, Inc. dba Mindray North America in September 11, 2024. Reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within …. Check the official notice for the remedy. Verify recall #Z-2951-2024 with the FDA Devices before acting.
The recall
Mindray Ds USA, Inc. dba Mindray North America issued this moderate-severity FDA Devices recall-V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within ….
- Moderate
- severity level
- 24 units
- affected scope
- Class II
- classification
- September 11, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2951-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2951-2024) was formally reported on September 11, 2024, with the manufacturer initiating the action on July 22, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Mindray Ds USA, Inc. dba Mindray North America is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 24 units.
The documented reason for this recall is: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will… Distribution data in the federal record shows the product reached: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: 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
24 units
Related Recalls
6
3 from same agency
Product description
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
Reason for recall
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2951-2024 |
| Date reported | September 11, 2024 |
| Date initiated | July 22, 2024 |
| Recalling firm | Mindray Ds USA, Inc. dba Mindray North America |
| Firm location | Mahwah, NJ |
| Affected scope | 24 units |
| Distribution | US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada |
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-2951-2024) 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? ▼
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00. Recalled by Mindray Ds USA, Inc. dba Mindray North America. Units affected: 24 units.
Why was this product recalled? ▼
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2024. Severity: Moderate. Recall number: Z-2951-2024.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2951-2024) 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 September 11, 2024. 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.