FDA Device recall Z-1467-2022
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal by Covidien, citing electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1467-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-07 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | AZ, CA, CO, IL, KS, MA, MI, MN, MO, NY, OK, PA, TN, TX, WA |
Product
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Reason
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Identifiers
| code_info | UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131,…UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1467-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.