Gyrus ACMI 190ARecalls & reported problems
Gyrus ACMI, LLC · Glass Body For 194 Ellik Evacuator · Class 2
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
- May 5, 2026Open, Classified
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Z-2721-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 18, 2025Open, Classified
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2141-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
Other EVACUATOR, GASTRO-UROLOGY devices
- AHTO 0250070600Stryker Corporation · EVACUATOR, GASTRO-UROLOGY2 recalls44 reports
- Toomey 188Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188AGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- USA Elite 191-NRSGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 190-4Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 194-2Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Bard® Ellik Evacuator 000451C. R. Bard, Inc. · EVACUATOR, GASTRO-UROLOGY42 reports
- Urovac Bladder Evacuator M0067301250Boston Scientific Corporation · EVACUATOR, GASTRO-UROLOGY10 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.
How reports and recalls are matched · Editorial policy · Report an error on this page