Severity
Moderate
FDA Devices recall · Reported September 7, 2016
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
Mindray Ds USA, Inc. dba Mindray North America recalled A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or … - a moderate-severity action.
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or … was recalled by Mindray Ds USA, Inc. dba Mindray North America in September 7, 2016. Reason: Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery S…. Check the official notice for the remedy. Verify recall #Z-2689-2016 with the FDA Devices before acting.
The recall
Mindray Ds USA, Inc. dba Mindray North America issued this moderate-severity FDA Devices recall-Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery S….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2689-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2689-2016) was formally reported on September 7, 2016, with the manufacturer initiating the action on June 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. 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 167 units (165 units - US) and (2 units - International).
The documented reason for this recall is: Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System. Distribution data in the federal record shows the product reached: US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and 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.
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.
Severity
Moderate
Affected scope
167 units (165 units - US) and (2 units - International)
Related Recalls
6
3 from same agency
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2689-2016 |
| Date reported | September 7, 2016 |
| Date initiated | June 15, 2016 |
| Recalling firm | Mindray Ds USA, Inc. dba Mindray North America |
| Firm location | Mahwah, NJ |
| Affected scope | 167 units (165 units - US) and (2 units - International) |
| Distribution | US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and 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.
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.
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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 7, 2016. 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.