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Oscor Inc. FDA Recalls
5 recalls on file across devices, 3 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F,Class IJun 10, 2026Due to manufacturing issues, there is a potential for the 14 |
| Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F Class IJun 10, 2026Due to manufacturing issues, there is a potential for the 14 |
| Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F.Class IJun 10, 2026Due to manufacturing issues, there is a potential for the 14 |
| Destino Twist 14F (also branded as Guidestar 14F)Class IIDec 22, 2021There is potential for separation between the threaded hub a |
| AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various typeClass IIMar 10, 2021Potential for open seal on sterile product |