Data Foundry

Medical device recalls 2022

TruClear Hysteroscopic Tissue Removal System Control Unit- designed… — Class II medical device recall Z-1467-2022

Ongoing recall by Covidien Llc, reported 2022-08-03, distributed in AZ, CA, CO, IL, KS, MA, MI, MN…. Electrical component failure within the control unit. The observed failure mode is a loss of function of the d

Recall numberZ-1467-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien Llc, Mansfield, MA, United States
Recall initiated2022-06-07
Classified2022-07-26
Reported by FDA2022-08-03
DistributedAZ, CA, CO, IL, KS, MA, MI, MN, MO, NY, OK, PA, TN, TX, WA
Countries outside the USES, GB, IE, NL
Quantity33 units
UPC / GTIN / UDI-DI10884521749931
Serial numbersYF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166 and 8 more
Model numbers7209808

Product

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1467-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.