FEI 1038963
Bsn Medical, Inc.
5825 CARNEGIE BLVD., CHARLOTTE, NC, US
MDR events20All time
Recalls1All time
Registered products26
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
26 product codes
Recent MDR events
20 on file
- BANDAGE KIT, COMPRESSION COMPRI2 LITE 9 3/4IN X 12 1/2INMay 28, 2026InjuryMW5188662
- BANDAGE KIT, COMPRESISON COMPRI2 LITE 9 3/4IN X 12 1/2INMay 28, 2026InjuryMW5188663
- JOBST ACTIVE COMPRESSION STOCKINGNov 12, 2025MalfunctionMW5178882
- AMERICAN ORTHOPEDICSep 24, 2025Malfunction23132237
- DELTA-CAST SERENEJul 22, 2025Injury1038963-2025-00002
- SPECIALIST(R) STERILE COTTON BLEND STERILE CAST PADDINGApr 25, 2025MalfunctionMW5169527
- DELTA-CAST® SERENEApr 25, 2025Injury1038963-2025-00001
- AMERICAN ORTHOPAEDIC CAST CUTTER - HEX DRIVENov 25, 2024Malfunction20770986
- BSN MEDICALJun 11, 2024Malfunction19508959
- SPECIALIST®Apr 4, 2023Malfunction16673521
Compliance history
Matched by FEI 1038963.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 5, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Sep 5, 2025
Design validation - simulated testing
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.