Gyrus ACMI 240044Recalls & reported problems
Gyrus ACMI, LLC · PAPARELLA-TYPE VENT TUBE 1.02 MM I.D. SILICONE · Class 2 · Implant
Data updated Oct 16, 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.
1 other recall cover devices cleared under the same FDA submission (K932166); they may or may not involve this specific model.
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
- Dec 11, 2023Open, Classified
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
Z-1004-2024 · Root cause: Employee error · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K932166. One submission often covers many models, so check the product and lot details in each record.
- Z-0707-2025 · Nov 19, 2024 · Open, ClassifiedDuravent Silicone Ventilation Tube. Model Number: 240075.
Other TUBE, TYMPANOSTOMY devices
- NeoZoline NZ3321Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3312-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3306-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3312Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3321-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3309Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3309-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3306Adept Medical Limited · Tube, Tympanostomy1 recall0 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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