Biosense Webster recalls specific Carto Vizigo Bi-Directional Guiding Sheaths due to incorrect labeling on carton versus inner pouch. This mismatch may cause confusion during medical procedures. Affected units include lot #00002137 with UDI 1084683:5016253.
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
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📍Recalling firmBiosense Webster, Inc.31 Technology Dr Ste 200 · Irvine, CA 92618-2302
✎ GovInfoNow plain-language explainer
Biosense Webster is recalling certain Carto Vizigo Bi-Directional Guiding Sheaths because the product name, lot number, and code on the outer carton label don't match the inner pouch label. This labeling error could lead to confusion during medical procedures, potentially affecting patient safety. Read more at govinfonow.com/recall/58860-biosense-webster-carto-vizigo-sheath-recall-incorrect-labeling-hazard.
“Biosense Webster Carto Vizigo Sheath Recall: Incorrect Labeling Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58860-biosense-webster-carto-vizigo-sheath-recall-incorrect-labeling-hazard. Based on FDA recall #Z-1319-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1319-2023%22&limit=1).
Biosense Webster, Inc. recalled the Carto Vizigo Bi-Directional Guiding Sheath due to incorrect labeling where carton labels do not match inner pouches, according to the FDA on Feb. 21, 2023.
The product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch.
Context
GovInfoNow's records show Biosense Webster, Inc. has 7 other recalls on record since June 14, 2017. Other recent recalls of similar products include Covidien Shiley Tracheostomy Tube Recall (April 15, 2026), Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026) and Omnicell i.v.Station Label Stock Recall (March 25, 2026).
How to tell if you have this one
Check for the lot number 00002137 and UDI (GTIN) 10846835016253 on the carton label. The product is a sterile, 8.5F (Small) Bi-Directional Guiding Sheath with reference code D-1385-01-S and RX CE 2797.
Brand
Biosense Webster
Category
Medical device
FDA recall event · 2 products
All 2 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
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.
Verify the carton label matches the inner pouch label for product name, lot number, and code.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1319-2023 (February 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1319-2023 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.