CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Leep Precision Integrated System recalled by CooperSurgical
CooperSurgical is recalling Leep Precision Integrated System, 220V CooperSurgical part numbers: Lp-10-220, distributed nationwide in the US. The recall was initiated on 29 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0258-2022
- FDA event ID
- 88648
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 29 Sep 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +50 days |
| 24 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Where it was distributed
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 2017040001 2017040002 2017040003 2017040004 2017040005 2018030001 2018030002 2018030003 2018030004 2018100004 2018100005 2018100006 2018120001 2018120002 2018120003 2019010001 2019010002 2019010003 2019010004 2019010005 2019030001 2019030002 2019030003 2019030004 2019070001 2019070002 2019070003 2019070004 2019070005 2019070006 2019100001 2019100004 2019100005 2019120001 2019120002 2019120003 2019120004 2019120005 2019120006 2020030001 2020030002 2020030003 2020030004 2020030005 2020060001 2020060002 2020060003 2020060004 2020060005 2020060006 2020080001 2020080002 2020080003 2020080004 2020080005 2020080006 2020110001 2020110002 2020110003 2020110004 2020110005 2020110006 2020120001 2020120002 2020120003 2020120004 2020120005 2020120006 2021010001 2021010002 2021010003 2021010004 2021010005
Where was it sold?
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 88648This product is part of a recall event; the main page for the event is Quantum 2000 Electrosurgical Generators Cooper Surgical recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Other | Nationwide | |
| CLASS II | Leep Precision Generator 220V Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Leep Precision Integrated System, 120V CooperSurgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Leep Precision Generator 120V Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide |
More recalls from CooperSurgical
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit with IV Tube recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |