OSCOR INC.

Activity by year

Devices registered here (1)

• Introducer, Catheter
  Product code DYB (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1340

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.

FDA inspections (3)

• VAI2021-09-10
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
• OAI2017-03-23
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
• OAI2016-03-17
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2016-06-13
  Warning Letter (opens in a new tab) · Palm Harbor Florida

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by OSCOR INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)