Class I — Oscor, Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| Product | 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 outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box. |
| Quantity | 36,688 units |
| 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, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORD… |
| Initiated | 2018-09-26 |
| Classified | 2018-11-08 |
| Terminated | 2022-08-04 |
| Recall number | Z-0391-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Oscor, Inc. (Z-0391-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80984/
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