CLASS II Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
GI4000 Electrosurgical Unit recalled by Steris
Steris is recalling GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform, distributed nationwide in the US. The recall was initiated on 17 Oct 2022 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-0241-2023
- FDA event ID
- 91020
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2022
- FDA classified
- 16 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 17 Oct 2022 | Recall initiated by company | |
| 16 Nov 2022 | Classified by FDA | +30 days |
| 23 Nov 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
Where it was distributed
US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
Questions about this recall
Is GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform recalled?
Yes. Steris recalled GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform on 17 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0241-2023.
Why was it recalled?
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result
Which lots are affected?
UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002
Where was it sold?
US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.
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 21 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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