Reported Aug 3, 2022 · Ongoing

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue…

Covidien LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal
  • Model Number7209808
Lot codes and dates
  • 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
Amount recalled
33 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.