Bioseal
167 WEST ORANGETHORPE AVE., PLACENTIA, CA, US
Registered product codes
129 product codes
Recent MDR events
23 on file
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186616
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186617
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186618
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186619
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186620
- MOGEN CLAMPApr 9, 2026MalfunctionMW5186621
- KIT SIGMOIDOSCOPE LIGHTED SGL USE STRLMar 9, 2026MalfunctionMW5184910
- BIOBLUE MOGEN CIRCUMCISION CLAMP 3Jan 14, 2026InjuryMW5182227
- BIOSEALJun 5, 2025Malfunction22148787
- MOGEN CIRCUMCISION CLAMPFeb 14, 2025Malfunction21383604
Recalls
5 on file
- CompletedUnknown
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
View FDA record ↗ - CompletedUnknown
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
View FDA record ↗ - CompletedUnknown
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
View FDA record ↗ - CompletedUnknown
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
View FDA record ↗ - TerminatedUnknown
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
View FDA record ↗
Compliance history
Matched by FEI 2027062.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
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.