LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterile barrier breach, which poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors (ASY 3/16 X 3/16 STR CONNW/LL24). The recall is limited to Lot 2002800186, which contains 24 units per package. The firm identified through internal testing that the sterile barrier of these connectors may present a breach.
The issue potentially affects components assembled with a specific packaging and is associated with a specific production period. The affected products were distributed in the United States to Alaska, Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. One unit was also distributed to Hospital de Barsuto in Bilbao, Spain.
The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in the source text. Users should check their inventory for Lot 2002800186 and stop using the affected connectors.
The recalled product
- Product
- Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT 2002800186
Distribution
Part of a larger recall action
This product is one of 22 recalled by LivaNova USA Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · LivaNova USA Inc.
See all →- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighVNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
- HighVagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
FDA (Devices) · 2022-02-09
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08