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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91797

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Biosense Webster, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Z-1319-2023
Recall number
Z-1319-2023
Initiated
February 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biosense Webster, Inc.
Quantity
277

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 00002137; UDI (GTIN) : 10846835016253

Distribution pattern

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.

device · product 2 of 2

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

Z-1320-2023
Recall number
Z-1320-2023
Initiated
February 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Biosense Webster, Inc.
Quantity
316 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 50000224; UDI (GTIN) : 10846835016277

Distribution pattern

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.