n.a. 810505Recalls & reported problems
Karl Storz GmbH & Co. KG · Needle, Septum, bayonet-shaped · Class 1
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
- Oct 24, 2023Open, Classified
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Z-0574-2024 · Root cause: Device Design · FDA record ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
- n.a. 738758Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 810506Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738752Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723400Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738750Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738756Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723014Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- RELIEVA SPINPLUS NAV RSP0616MFSNAcclarent, Inc. · INSTRUMENT, ENT MANUAL SURGICAL1 death27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.