Severity
Moderate
FDA Devices recall · Reported July 8, 2020
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with …
Westmed, Inc. recalled Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resusc… - a moderate-severity action.
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resusc… was recalled by Westmed, Inc. in July 8, 2020. Reason: A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and…. Check the official notice for the remedy. Verify recall #Z-2434-2020 with the FDA Devices before acting.
The recall
Westmed, Inc. issued this moderate-severity FDA Devices recall-A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2434-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2434-2020) was formally reported on July 8, 2020, with the manufacturer initiating the action on January 15, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Westmed, Inc. is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 625 cases.
The documented reason for this recall is: A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via th… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain.. 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
625 cases
Related Recalls
6
3 from same agency
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2434-2020 |
| Date reported | July 8, 2020 |
| Date initiated | January 15, 2019 |
| Recalling firm | Westmed, Inc. |
| Firm location | Tucson, AZ |
| Affected scope | 625 cases |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain. |
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 July 8, 2020. 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.