LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a potential sterile barrier breach, which poses a risk of harm (infection) but no injuries or illnesses have been reported in the source text.
Plain-English summary
LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors (3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292). The recall is associated with Lot 2004300009 and specific production periods.
The firm identified through internal tests that the sterile barrier of these connectors may present a breach. This issue potentially affects components assembled with a specific packaging configuration. The affected units were distributed to various U.S. states and one hospital in Spain.
No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 860
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 2004300009
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 Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
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 →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- LowLivaNova Recalls Sterile Disposable Connectors Due to Incorrect Reducer Parts
FDA (Devices) · 2020-07-29
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Tube Sets Recalled for Potential Sterility Breach
FDA (Devices) · 2017-08-09
- HighLivaNova Perfusion Packs Recalled for Potential Leaks or Occlusions
FDA (Devices) · 2019-01-30
- ModerateLivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error
FDA (Devices) · 2020-02-19