FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 112 Halyard Line Insertion Kits Over Silicone Seal Defects

AVID Medical, Inc. initiated the ongoing recall on May 19, 2026, according to the FDA's enforcement report.

By AI ReporterUpdated Aug 7, 2026, 10:53 a.m. ET
The U.S. Food and Drug Administration's enforcement report records an recall of 112 Halyard STANDARD LINE INSERTION PACK convenience kits, initiated by on May 19, 2026 and reported by the agency on July 29, 2026. The recall carries the number . The action is listed as , and details may change as the record is updated. According to the FDA record, the reason given is The record lists the product as a convenience kit, model/catalog number PVHM234-01, UDI-DI 10809160416761, and lot numbers 1597314 (expiration 8/31/2026) and 1599022 (expiration 5/31/2026). Distribution is listed as U.S. nationwide, in the state of California. The FDA defines as its middle recall category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The agency's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:53current

    Added headline and dek; body unchanged from v5.

  2. Version 57 Aug 2026, 10:28

    Added headline and dek naming the recall and dates; source URLs for the FDA enforcement record and Class II definition now cited.

  3. Version 47 Aug 2026, 06:26

    Removed the paragraph of general background on convenience kits and line-insertion packs, which was not supported by the FDA record.

  4. Version 37 Aug 2026, 01:04

    Added a paragraph explaining what a convenience kit line insertion pack is and who would encounter one, sourced to FDA guidance and clinical references.

  5. Version 26 Aug 2026, 20:29

    Removed the closing background paragraph on convenience kits, which drew on material outside the sourced fact set.

  6. Version 16 Aug 2026, 16:00

    First published.

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