Oscor Inc.

FDA recalling firm · 7 enforcement events · 39 product records · 2012–2026 · FL

Oscor Inc. has 7 FDA enforcement events on this register (39 product records) between 2012 and 2026: 7 device; the busiest year was 2021 with 2.

43% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
10 Jun 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.	Device	Class I	3	Ongoing
22 Dec 2021	Destino Twist 14F (also branded as Guidestar 14F)	Device	Class II	1	Completed
10 Mar 2021	AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.	Device	Class II	1	Terminated
26 Sep 2018	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 tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The…	Device	Class I	1	Terminated
31 Mar 2017	ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM…	Device	Class I	2	Terminated
5 Oct 2016	OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.	Device	Class II	30	Terminated
25 Jul 2012	Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.	Device	Class II	1	Terminated

By type and class

Device7

Class II4

Class I3

Class I: 43% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Oscor Inc. by year initiated.

Questions and answers

How many FDA recalls has Oscor Inc. had?

7 enforcement events (39 product records) on this register, 2012–2026: 7 device.

Are any Oscor Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Oscor Inc. recalls?

4 Class II, 3 Class I. 43% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.