Palm Harbor, FL, United States
Oscor Inc. recalls
4 recalls recorded since 2018, most recently on 10 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 10 June 2026
- 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.
- Distribution
- Distribution in the US state of MA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2678-2026, Z-2679-2026, Z-2680-2026
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Completed Class II Medical devices
- Recall started
- 22 December 2021
- Reason
- There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
- Distribution
- Distribution to TN and PA in USA OUS distribution to Czech Republic
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0646-2022
- Destino Twist 14F (also branded as Guidestar 14F)
Terminated Class II Medical devices
- Recall started
- 10 March 2021
- Terminated
- 8 August 2023
- Reason
- Potential for open seal on sterile product
- Distribution
- US Nationwide distribution in the state of New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1329-2021
- AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Terminated Class I Medical devices
- Recall started
- 26 September 2018
- Terminated
- 4 August 2022
- Reason
- During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0391-2019
- TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tra
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.