OVERLOOKED

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Class IOngoing

Oscor Inc. recalls 3 products

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Oscor Inc.
Reason
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Distribution in the US state of MA
Where
Massachusetts
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99102…

Products (3)

  1. Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

    Codes/lots: All Lots within Expiry/GTIN:00885672009793, 00813502010664Quantity: 355 unitsRecall no. Z-2678-2026Class I

  2. Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.

    Codes/lots: All Lots within Expiry/GTIN:00885672009786/00813502010558Quantity: 1332 unitsRecall no. Z-2679-2026Class I

  3. Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.

    Codes/lots: All Lots within Expiry/GTIN:00885672009755/00813502011609Quantity: 32,934 unitsRecall no. Z-2680-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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