Oscor Inc. medical device recall: Abiomed REF: 0052-3025
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99102
- Recall initiated
- Jun 10, 2026
- Classified by FDA
- Jul 10, 2026
- Posted in Enforcement Report
- Jul 22, 2026
- Recalling firm
- Oscor Inc.
- Firm location
- Palm Harbor, FL, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 10, 2026. FDA classified it 30 days later, on Jul 10, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Distribution in the US state of MA Oscor Inc. has 7 recalls in our records.
Recalled products (3)
Z-2678-2026 Class I Ongoing
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, 00813502010664
Quantity: 355 units
Z-2679-2026 Class I Ongoing
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:00885672009786/00813502010558
Quantity: 1332 units
Z-2680-2026 Class I Ongoing
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:00885672009755/00813502011609
Quantity: 32,934 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99102
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.