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Data refreshed July 28, 2026 · last 180 days

503recalls · last 30 days
40CPSC · last 30 days
394FDA · last 30 days
66NHTSA · last 30 days
3FSIS · last 30 days
3,503in 180-day window

Oscor Inc. recalls

RecallSweep is tracking 3 recall notices naming Oscor Inc. in the last 180 days, issued by FDA. The most recent is dated July 22, 2026. They cover Medical Devices. 3 carry a Class I or Do Not Drive designation.

This page lists what the issuing agencies published. It is not a statement about Oscor Inc. beyond those notices — open each official notice for the authoritative detail.

Recall notices naming Oscor Inc.

3 recalls.

FDA Class I Medical Devices

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

Affected quantity: 355 units

Hazard
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.

Details
Distribution: Distribution in the US state of MA. Recall #Z-2678-2026, initiated 20260610. Voluntary: Firm initiated.

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

Recall status
Ongoing

Look up recall #Z-2678-2026 in the FDA enforcement database ↗
FDA Class I Medical Devices

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

Affected quantity: 1332 units

Hazard
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.

Details
Distribution: Distribution in the US state of MA. Recall #Z-2679-2026, initiated 20260610. Voluntary: Firm initiated.

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

Recall status
Ongoing

Look up recall #Z-2679-2026 in the FDA enforcement database ↗
FDA Class I Medical Devices

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

Affected quantity: 32,934 units

Hazard
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.

Details
Distribution: Distribution in the US state of MA. Recall #Z-2680-2026, initiated 20260610. Voluntary: Firm initiated.

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

Recall status
Ongoing

Look up recall #Z-2680-2026 in the FDA enforcement database ↗

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