GYRUS ACMI, INCRecalls & reported problems across all models
Gyrus ACMI, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one GYRUS ACMI, INC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of GYRUS ACMI, INC by Gyrus ACMI, LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
GYRUS ACMI, INC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 25, 2026Open, Classified
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Z-1643-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Sep 11, 2024Open, Classified
Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
Z-0364-2025 · Root cause: Storage · Recall details · FDA record ↗
GYRUS ACMI, INC models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GYRUS ACMI, INC 61038BXACCESSORIES, CATHETER, G-U1 recall0 reports
- GYRUS ACMI, INC 920000PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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