Ultracell 40825Recalls & reported problems
Beaver-Visitec International, Inc. · Eye Pledgets · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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 · FDA record ↗
Other Sponge, ophthalmic devices
- Ultracell 40430Beaver-Visitec International, Inc. · Sponge, ophthalmic1 recall0 reports
- MICROSPONGE 8065100003Alcon Laboratories, Inc. · Sponge, ophthalmic2 reports
- Ultracell BS40400-8Beaver-Visitec International, Inc. · Sponge, ophthalmic2 reports
- DeRoyal 30-049Deroyal Industries, Inc. · Sponge, ophthalmic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.