Synergetics 18069WRecalls & reported problems
Synergetics USA, Inc. · I-PACK Injection Kit With Speculum · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's 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, 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 16, 2026.
Recalls naming this device
- Jun 12, 2024Open, Classified
Sterilization certificates could not be validated by the supplier
Z-2254-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 5, 2024Open, Classified
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Z-2336-2024 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗
Other Kit, Surgical Instrument, Disposable devices
- Medline Industries, Inc. DYNJ59816AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18061Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ83185AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18069Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ69761Medline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ24628MMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- CustomEyes® 58001713Beaver-Visitec International, Inc. · Kit, surgical instrument, disposable2 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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