FDA Device recall Z-1213-2024
Colonoscope, Model Number PCF-HQ190L
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Colonoscope, Model Number PCF-HQ190L by Olympus, citing specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temper….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1213-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-11 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Colonoscope, Model Number PCF-HQ190L.
Reason
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Identifiers
| code_info | Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860,…Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200, 2307709, 2307713, 2308226; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1213-2024%22
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