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.
Take action
Contact the company
📍Recalling firmLivaNova USA Inc.14401 W 65th Way · Arvada, CO 80004-3503
“LivaNova Sterile Connector Recall: Wrong Size Connector in Some Packages.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66505-livanova-sterile-connector-recall-wrong-size-connector-in-some-packages. Based on FDA recall #Z-2642-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2642-2020%22&limit=1).
The FDA announced on November 18, 2019, that LivaNova USA Inc. is recalling its Sterile Disposable Connectors because some packages contained incorrect reducer fittings instead of the specified connectors. The agency stated no significant health risk is expected as the issue is easily detectable.
How to tell if you have it
Brand: LivaNova
Product: LivaNova USA Sterile Disposable Connector, 1/2x1/2, 20 units per case
Item#: EC2135S
Lot No.: 1923900091
Quantity: 140 units
The hazard
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. The FDA noted that no significant risk to health is expected because the issue is easily detectable and the different shape would prevent use of the connector.
Context
GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since January 24, 2018. Recent brand recalls include a January 3, 2025 recall regarding potential therapy delivery stops in implanted pulse generators and a December 12, 2024 recall of SenTiva VNS Generators due to stimulation delivery risks. Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (January 7, 2026) and Avanos CORFLO Safety PEG Kit with ENFit Connector Recall: Sterile Kit Contamination Risk (April 30, 2026).
How to tell if you have this one
Check for the item number EC2135S and lot number 1923900091 on the packaging. The affected connectors are sold in cases of 20 units.
Brand
LivaNova
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Connector Size
Inspect the connector to see if it matches the 1/2x1/2 size; if not, it's part of the recall.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2642-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2642-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.