Oscor Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000005944 FEI 1035166
Oscor Inc. is a medical device manufacturer based in the United States, with 1,319 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II, III and I; EU Class III) and 42 FDA recalls as of 12 Nov 2026.
- Devices
- 1,319
- Registrations
- EUDAMEDFDA
- FDA recalls
- 423 ongoing
Registry facts
- Registries
- FDA GUDID 1,232
- EUDAMED 506
- FDA 510(k) 49
- Device classes
- FDA Class II 1,229
- EU Class III 49
- FDA Class III 40
- FDA Class I 1
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000005944
- FDA FEI 1035166
- DUNS 101835833
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 1,319 devicesShowing 1-50 of 1,319
Company details
- EUDAMED SRN
- US-MF-000005944
- FDA FEI number
- 1035166
- DUNS number
- 101835833
- EU VAT number
- 592276224
- EUDAMED status
- Active
- EUDAMED registered name
- Oscor Inc.
- Registered address
- 4875, Palm Harbor Blvd., FL 34683, Palm Harbor, United States
- Website
- www.oscor.com
- Phone
- +1 727 937 2511
- PRRC contact
- Mohit Malkani
FDA recalls
Recalls initiated per year
- 2017 2
- 2018 1
- 2019 0
- 2020 0
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 3
2026
- 10 Jun 2026 Z-2678-2026 Class I Ongoing 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.
- 10 Jun 2026 Z-2679-2026 Class I Ongoing 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.
- 10 Jun 2026 Z-2680-2026 Class I Ongoing 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.
2021
- 22 Dec 2021 Z-0646-2022 Class II Completed There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
- 10 Mar 2021 Z-1329-2021 Class II Terminated Potential for open seal on sterile product
2018
- 26 Sep 2018 Z-0391-2019 Class I Terminated 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.
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- 26 Sep 2018 Z-0391-2019 Class I Terminated 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.
2017
- 31 Mar 2017 Z-2340-2017 Class I Terminated The Reusable Oscor ATAR extension cables could separate from the connector during use.
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- 31 Mar 2017 Z-2733-2017 Class I Terminated The Reusable Oscor ATAR extension cables could separate from the connector during use.
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- 31 Mar 2017 Z-2340-2017 Class I Terminated The Reusable Oscor ATAR extension cables could separate from the connector during use.
2016
- 5 Oct 2016 Z-0790-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0791-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0790-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Show the 25 most recent of 42 recalls
2016
- 5 Oct 2016 Z-0792-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0793-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0794-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0795-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0796-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0797-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0798-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0799-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0800-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0801-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0802-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0803-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0804-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0805-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0806-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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- 5 Oct 2016 Z-0792-2017 Class II Terminated Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Frequently asked questions
How many devices does Oscor Inc. have in the registry?
The registry currently lists 1319 devices for Oscor Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oscor Inc.'s devices?
Among its 50 most recently registered devices, Oscor Inc. has devices listed in EUDAMED (46 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oscor Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Oscor Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Oscor Inc.?
FDA recall records list 42 recalls initiated by Oscor Inc., the most recent initiated on 10 Jun 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Oscor Inc. in the registry?
The most recently registered devices listed for Oscor Inc. include Aptus Tourguide, Arrive Braided Transseptal Sheath, SafeSheath II and Adelante Peel-Away Introducer.