CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report

Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED recalled

LivaNova USA is recalling Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24, distributed in 44 states. The recall was initiated on 24 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT 2004300006

Quantity recalled96 units

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-2450-2020
FDA event ID: 85623
Recalling firm: LivaNova USA, Arvada, CO
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2020
FDA classified: 26 Jun 2020
Reported: 8 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 Apr 2020	Recall initiated by company
26 Jun 2020	Classified by FDA	+63 days
8 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

The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

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

Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269

Where it was distributed

US - 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 OUS- Spain (Hospital de Barsuto, Bilbao, Spain)

Alaska Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

Which lots are affected?

LOT 2004300006

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

21 other products · FDA event 85623

This product is part of a recall event; the main page for the event is Sterile Disposable Connectors Asy 1/2 Conn W/LL Strle recalled.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy 1/2 Conn W/LL Strle recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Vein Irrigation Cannula with blunt tip recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY RDC Y 1///8 STR recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Str Conn 1/4 Strle recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY S CONN 3//8 RDR ANLD24 recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY Y CONN 3///8 recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Conn Equal 3/16 Wye recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	3///8 Y Conn, Strl recalled by LivaNova USA	LivaNova USA	Other	44 states
8 Jul 2020	CLASS II	1//8 Reduc Conn, Strl recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	3/8 Str Conn, Strl recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Conn Reducer 3//4 recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Conn Reducer 1//8 recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY 3//16 STR Connw/LL24 recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	1/2 - 3/8 Reduc Conn, Strl recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY Y CONN 1///4 recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	1///16yconn,strl recalled by LivaNova USA	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Str Conn 3/8 Strle recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors Asy Str Conn 3/16 Strle recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY 1//8 Reducer W/LL recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Sterile Disposable Connectors ASY CONN Y 1///8 STR recalled	LivaNova USA	Sterility	44 states
8 Jul 2020	CLASS II	Vein Irrigation Cannula with blunt tip recalled by LivaNova USA	LivaNova USA	Sterility	44 states

More recalls from LivaNova USA

All 47

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS II	SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled	LivaNova USA	Other	41 states
12 Feb 2025Device	CLASS II	SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled	LivaNova USA	Other	41 states
5 Feb 2025Device	CLASS II	VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA	LivaNova USA	Packaging Defects	Nationwide
9 Feb 2022Device	CLASS II	Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled	LivaNova USA	Device Malfunction	7 states
16 Dec 2020Device	CLASS II	VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA	LivaNova USA	Other	TX

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