CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
Gyrus Acmi PKS Omni/-intended recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Gyrus Acmi PKS Omni/-intended for the electrosurgical coagulation, mechanical grasping, distributed nationwide in the US. The recall was initiated on 9 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2380-2021
- FDA event ID
- 88448
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2021
- FDA classified
- 27 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 9 Jun 2021 | Recall initiated by company | |
| 27 Aug 2021 | Classified by FDA | +79 days |
| 8 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Product as listed by the FDA
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Where it was distributed
US Nationwide distribution in the states of CA, GA, MN, TN.
Questions about this recall
Why was it recalled?
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Which lots are affected?
Lot number KR121617
Where was it sold?
US Nationwide distribution in the states of CA, GA, MN, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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