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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91488

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beaver Visitec International, 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

Ultracell Wick with 80cc Collection Bag, 20/box

Z-1199-2023
Recall number
Z-1199-2023
Initiated
December 20, 2022
Classification
Class II
Status
Ongoing
Quantity
4640 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging may contain open seals, compromising product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device packaging may contain open seals, compromising product sterility.

Code information

Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123

Distribution pattern

US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

device · product 2 of 2

CustomEyes kits

Z-1200-2023
Recall number
Z-1200-2023
Initiated
December 20, 2022
Classification
Class II
Status
Ongoing
Quantity
4640 units in total

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging may contain open seals, compromising product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device packaging may contain open seals, compromising product sterility.

Code information

Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

Distribution pattern

US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa