CooperSurgical, Inc. LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRAT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRAT
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
2018110001, 2018110002, 2018110003, 2018110004, 2018110005, 2018110006, 2018110007, 2018110008, 2018110011, 2018110012, 2018110013, 2018110014, 2018110015, 2018110016, 2018110017, 2018110019, 2018110020, 2018110021, & 2018110022
Products Sold
2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,2018110013, 2018110014, 2018110015,2018110016, 2018110017, 2018110019, 2018110020,2018110021,& 2018110022
CooperSurgical, Inc. is recalling LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRA due to 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
Recommended Action
Per FDA guidance
On April 23, 2019, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to immediately discontinue use of the discrepant product, quarantine the product, and replace the 2 main fuses with the 2 fuses provided with the firm's mailing. Customers were provided with instructions to replace the fuses. Once customers have successfully completed the fuse replacement, they are asked to complete the Acknowledgement and Receipt form and return it to CooperSurgical. If you have any questions, please contact the firm at 203-601-5200 ext. 3300.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026