Severity
Critical
FDA Devices recall · Reported May 24, 2023
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Draeger Medical, Inc. recalled Anesthesia Set Coax 180, MP03384 - a critical-severity action.
Anesthesia Set Coax 180, MP03384 was recalled by Draeger Medical, Inc. in May 24, 2023. Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial…. Check the official notice for the remedy. Verify recall #Z-1458-2023 with the FDA Devices before acting.
The recall
Draeger Medical, Inc. issued this critical-severity FDA Devices recall-Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1458-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1458-2023) was formally reported on May 24, 2023, with the manufacturer initiating the action on April 17, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Draeger Medical, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 20 units.
The documented reason for this recall is: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. Distribution data in the federal record shows the product reached: Domestic: US Nationwide Distribution.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
20 units
Related Recalls
6
3 from same agency
Anesthesia Set Coax 180, MP03384
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1458-2023 |
| Date reported | May 24, 2023 |
| Date initiated | April 17, 2023 |
| Recalling firm | Draeger Medical, Inc. |
| Firm location | Telford, PA |
| Affected scope | 20 units |
| Distribution | Domestic: US Nationwide Distribution. |
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 May 24, 2023. 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.