Otopore 5400010000Recalls & reported problems
Stryker Corporation · Cylinder Standard · Class 2
All models of Otopore (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 25, 2025Class IIOpen, Classified
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Z-1469-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE devices
- Otopore 5400020100Stryker Corporation · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE1 recall0 reports
- PuraSinus 5mL 651-0093-D Matrix Inc. · Polymer, Ear, Nose And Throat, Synthetic, Absorbable1 recall0 reports
- Otopore 5400020000Stryker Corporation · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE1 recall0 reports
- LATERA LATANI02Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable12 reports
- LATERA LATSYS24Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable8 reports
- 1.5 LACTOSORB SYSTEM 915-2315Biomet Microfixation, Inc · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE3 reports
- LATERA LATSYS20Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable3 reports
- LATERA LATANI24Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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