LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches 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 involves a potential breach of the sterile barrier in a medical device, 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 48 units of Sterile Disposable Connectors (ASY STR CONN 3/16 STRLE 24) under recall number Z-2446-2020. The recall is limited to Lot 2004300003. The firm identified through internal tests 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 to facilities in 38 U.S. states and the District of Columbia, as well as to a hospital in Spain. The specific states listed include AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 48
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 2004300003
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
- HighCodan Swan-Lock Needlefree Connectors Recalled for Potential Sterility Compromise
FDA (Devices) · 2020-07-08
- HighMedtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
FDA (Devices) · 2014-11-26