FirstAlerts

FDA Closes AVID Medical Recall of Kits Containing Medline Manifolds

The agency has closed the recall action, confirming the correction is complete, and repeats the identifying codes for any remaining affected kits.

2 reports on this incident · first at Aug 31, 2026, 10:15 p.m. ET

By AI ReporterFirst reported Aug 27, 2026, 12:00 a.m. ETWritten Aug 31, 2026, 10:23 p.m. ET
Developing · checked 53 min ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 31, 2026, 10:39 p.m. ET — checked 53 min ago.

The U.S. Food and Drug Administration has closed the recall action involving convenience kits distributed by that contain Medline Manifolds, according to an agency notice. The closure means the FDA considers the correction carried out. The recall, classified as the , was prompted by Medline's identification of particulate within the fluid path of the Manifolds. As of June 30, had not reported any serious injuries or deaths associated with the issue, the FDA said. Affected kits carry one of the following identifying codes: 512628, EAMC1000-0510, 809160377314, 5313767, SELF131-0510, 809160408650, 5308991, SAMM066-1510, or 809160388495. The remedy instructed users to identify and quarantine affected kits and to add warning labels to ensure affected Manifolds are not used.

Earlier reports

  1. Aug 31, 2026, 10:15 p.m. ETFirst report

    FDA Classifies AVID Medical Kit Correction as Most Serious Type

    The U.S. Food and Drug Administration (FDA) has classified a correction by AVID Medical as the most serious type of recall, according to a notice published on fda.gov. The correction involves convenience kits containing Medline manifolds, identified by codes including 512628, EAMC1000-0510, and 809160377314. The notice lists nine codes in total; the remaining codes are available in the FDA notice.

    Medline identified the presence of particulate within the fluid path of the manifolds, prompting the correction. As of June 30, AVID Medical has not reported any serious injuries or deaths associated with this issue, the FDA reported.

    The FDA states the remedy is to identify and quarantine affected kits and add warning labels to ensure affected manifolds are not used. The status of the correction is ongoing.

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Revision history

  1. Version 11 Sept 2026, 02:15current

    First published.

  2. Version 11 Sept 2026, 02:23current

    First published.

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