Olympus Corporation of the Americas
FDA Regulatory Profile
Summary
- Total Recalls
- 378 (44 Class I)
- 510(k) Clearances
- 1
- Inspections
- 9
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1488-2026 | Class II | Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has | January 29, 2026 |
| Z-1489-2026 | Class II | Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 h | January 29, 2026 |
| Z-1354-2026 | Class I | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal | January 16, 2026 |
| Z-1353-2026 | Class I | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdomina | January 16, 2026 |
| Z-1352-2026 | Class I | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal c | January 16, 2026 |
| Z-1494-2026 | Class II | Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lit | January 8, 2026 |
| Z-1290-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Desc | January 7, 2026 |
| Z-1284-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC43 | January 7, 2026 |
| Z-1274-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software V | January 7, 2026 |
| Z-1297-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4 | January 7, 2026 |
| Z-1271-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software V | January 7, 2026 |
| Z-1273-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software V | January 7, 2026 |
| Z-1291-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Desc | January 7, 2026 |
| Z-1287-2026 | Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product De | January 7, 2026 |
| Z-1296-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Desc | January 7, 2026 |
| Z-1288-2026 | Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product De | January 7, 2026 |
| Z-1286-2026 | Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product De | January 7, 2026 |
| Z-1281-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4 | January 7, 2026 |
| Z-1277-2026 | Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC | January 7, 2026 |
| Z-1270-2026 | Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product De | January 7, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133538 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE | August 7, 2014 |