CLASS III Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
Sterile Disposable Connector recalled by LivaNova USA
LivaNova USA is recalling Sterile Disposable Connector,1, distributed in Kansas, Minnesota, Missouri, Utah, Washington. The recall was initiated on 18 Nov 2019 and the FDA has classified it as Class III.
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-2642-2020
- FDA event ID
- 85858
- Recalling firm
- LivaNova USA, Arvada, CO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Nov 2019
- FDA classified
- 17 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2019 | Recall initiated by company | |
| 17 Jul 2020 | Classified by FDA | +242 days |
| 29 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Where it was distributed
Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
Questions about this recall
Why was it recalled?
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
Which lots are affected?
Item# EC2135S, Lot No. 1923900091
Where was it sold?
Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from LivaNova USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA | LivaNova USA | Packaging Defects | Nationwide |
| Device | CLASS II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled | LivaNova USA | Device Malfunction | 7 states |
| Device | CLASS II | VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA | LivaNova USA | Other | TX |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |