UltracellRecalls & reported problems across all models
Beaver-Visitec International, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Ultracell model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of Ultracell by Beaver-Visitec International, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2022 and Sep 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Ultracell recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 20, 2022Open, Classified
Device packaging may contain open seals, compromising product sterility.
Z-1199-2023 · Root cause: Process control · Recall details · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1593-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Ultracell problems
Device problems
- Material Fragmentation2
Patient problems
- Foreign Body Sensation in Eye2
Ultracell models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultracell 40825Sponge, ophthalmic1 recall0 reports
- Ultracell 40430Sponge, ophthalmic1 recall0 reports
- Ultracell BS40400-8Sponge, ophthalmic2 reports
Recent Ultracell adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2022Material Fragmentation; Material Fragmentation
CUSTOMER ALLEGED THAT FIBERS WERE REMOVED FROM UNDER LASIK FLAP. ( 1 OF 2).
Patient problems: Foreign Body Sensation in Eye
MAUDE report 15452792 ↗MalfunctionSep 20, 2022Material Fragmentation; Material Fragmentation
CUSTOMER ALLEGED THAT FIBERS WERE REMOVED FROM UNDER LASIK FLAP.
Patient problems: Foreign Body Sensation in Eye
MAUDE report 15452791 ↗
Other Beaver-Visitec International, Inc. products
All Beaver-Visitec International, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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