LivaNova recalls sterile disposable connectors with specific lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during use.
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.
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Contact the company
📍Recalling firmLivaNova USA Inc.14401 W 65th Way · Arvada, CO 80004-3503
“LivaNova Sterile Connectors Recall: Potential Barrier Breach Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65291-livanova-sterile-connectors-recall-potential-barrier-breach-risk. Based on FDA recall #Z-2457-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2020%22&limit=1).
The FDA announced on April 24, 2020, that LivaNova USA Inc. recalled Sterile Disposable Connectors due to a potential breach of the sterile barrier. The agency classified the recall as Class II.
Internal tests identified that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue affects components assembled with specific packaging during a specific production period.
Context
GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since January 24, 2018. Recent similar product recalls include the Medtronic DLP Cannula Recall (April 21, 2026) and the Medline Convenience Kits Recall (June 12, 2026).
How to tell if you have this one
Check for the lot number 2003400088 on the connector packaging. The product has a specific GTIN: 00803622123382 and was sold with the insert label 050608000.
Brand
LivaNova
Category
Medical device
FDA recall event · 22 products
All 22 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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)
Recall number
Product, codes & lots
Quantity
Z-2443-2020
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153; LOT 2002800185
120 units
Z-2444-2020
Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184; LOT 2002800186
24 units
Z-2445-2020
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207; LOT 2003400081
24 units
Z-2446-2020
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214; LOT 2004300003
48 units
Z-2447-2020
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221; LOT 2004300004
48 units
Z-2448-2020
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252; LOT 2002800189
72 units
Z-2449-2020
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238; LOT 2004900013
648 units
Z-2450-2020
Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269; LOT 2004300006
96 units
Z-2451-2020
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276; LOT 2003400082
600 units
Z-2452-2020
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283; LOT 2003400083
96 units
Z-2453-2020
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290; LOT 2003400084
24 units
Z-2454-2020
Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306; LOT 2002800190
744 units
Z-2455-2020
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320; LOT 2002800191, 2003400085
984 units
Z-2456-2020
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351; LOT 2003400086
768 units
Z-2457-2020
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382; LOT 2003400088
240 units
Z-2458-2020
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278; LOT 2004900015
20 units
Z-2459-2020
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285; LOT2004300008
220 units
Z-2460-2020
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292; LOT 2004300009
860 units
Z-2461-2020
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315; LOT 2004900016; 2002800193
420 units
Z-2462-2020
1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322; LOT 2005500211; 2004300011
240 units
Z-2463-2020
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091; LOT 2004900018
150 units
Z-2464-2020
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107; LOT 2004300013; 2005500214
325 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number on the connector packaging to confirm if it matches 2003400088.
Where it went and when
Where it was distributed
Distributed in 43 states and D.C., and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “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)” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2457-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2457-2020 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.