Severity
Moderate
FDA Devices recall · Reported April 6, 2022
Product was distributed with incorrect expiration date.
Avanos Medical, Inc. recalled BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Si… - a moderate-severity action.
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Si… was recalled by Avanos Medical, Inc. in April 6, 2022. Reason: Product was distributed with incorrect expiration date.. Check the official notice for the remedy. Verify recall #Z-0847-2022 with the FDA Devices before acting.
The recall
Avanos Medical, Inc. issued this moderate-severity FDA Devices recall-Product was distributed with incorrect expiration date..
Sourced from official FDA Devices enforcement records. Verify recall #Z-0847-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0847-2022) was formally reported on April 6, 2022, with the manufacturer initiating the action on November 22, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Avanos Medical, Inc. is listed as the recalling firm, operating out of Alpharetta, GA. Federal records list the affected scope as 2,520 devices (126 cases).
The documented reason for this recall is: Product was distributed with incorrect expiration date. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.. 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
2,520 devices (126 cases)
Related Recalls
6
3 from same agency
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Product was distributed with incorrect expiration date.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0847-2022 |
| Date reported | April 6, 2022 |
| Date initiated | November 22, 2021 |
| Recalling firm | Avanos Medical, Inc. |
| Firm location | Alpharetta, GA |
| Affected scope | 2,520 devices (126 cases) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands. |
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 April 6, 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.