Data Foundry

Medical device recalls 2021

LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 — Class II medical device recall Z-0259-2022

Ongoing recall by CooperSurgical, Inc., reported 2021-11-24, distributed nationwide. Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue

Recall numberZ-0259-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCooperSurgical, Inc., Trumbull, CT, United States
Recall initiated2021-09-29
Classified2021-11-18
Reported by FDA2021-11-24
DistributedNationwide (US)
Countries outside the USAE, BO, CA, CL, CN, CR, DE, DO, EC, GB, HK, ID, IN, IR, IT, JO, KE, LK, MX, MY, NG, NI, NZ, PH, QA, SG, TH, TR, TT, TW, VN, ZA
Quantity244 units
Serial numbers0215002, 1214007, 2015050001, 2015050016, 2015050017, 2015050018, 2015050019, 2015050020, 2015110007, 2016030001, 2016030002, 2016030006, 2016030007, 2016030013, 2016030015, 2016040001, 2016040002, 2016040004, 2016040006, 2016040007, 2016040010, 2016050004, 2016050006, 2016050007, 2016050010 and 202 more
Model numbersLP-20-120

Product

LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120

Reason for recall

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

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-0259-2022. 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.