CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Leep Precision Generator 220V Cooper Surgical recalled
CooperSurgical is recalling Leep Precision Generator 220V Cooper Surgical, 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-0260-2022
- 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 Generator 220V Cooper Surgical Part Number: LP-20-220
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: 2018100001 2018100002 2018100003
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 | Leep Precision Integrated System recalled by CooperSurgical | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Other | 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 |