RegWardenFDA facility compliance records
Company

OSCOR INC.

7 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2016: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2021: 2 recalls; 2026: 1 recalls1’12’13’14’151’161’171’18’19’202’21’22’23’24’251’26
  • Recalls (7)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2026-06-10
    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.
  • Class IICompleted2021-12-22
    There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
  • Class IITerminated2021-03-10
    Potential for open seal on sterile product
  • Class ITerminated2018-09-26
    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 breaka…
  • Class ITerminated2017-03-31
    The Reusable Oscor ATAR extension cables could separate from the connector during use.
  • Class IITerminated2016-10-05
    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
  • Class IITerminated2012-07-25
    Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “OSCOR INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1035166-oscor-inc/

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