Agency classClass IIOur severity:High FDA (Devices)·Z-0241-2023·Announced 2022-11-23

GI4000 Electrosurgical Unit recalled due to power regulator failure risk

Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with potential for power loss during patient procedures. No injuries or illnesses have been reported. The hazard is a manufacturing defect that creates a theoretical risk of procedural disruption, meeting the criteria for High severity without reported harm.

Plain-English summary

Steris Corporation is recalling 5 GI4000 Electrosurgical Units due to a manufacturing defect in the controller circuit board. Two electronic diode components (D1 and D4) were placed in reverse orientation during manufacturing, which may cause premature wear of the power regulator.

If the power regulator fails during a patient procedure, the unit could lose all power output, resulting in a procedural delay. The affected units have the following serial numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002.

The units were distributed nationwide in Arizona, Illinois, Tennessee, and Virginia. Healthcare facilities that have received these units should stop using them immediately and contact Steris Corporation for replacement or repair instructions.

The recalled product

Product: 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
Manufacturer: Steris Corporation
Category: Medical Device — Endoscopic surgical equipment
Hazard: device-malfunction
power-loss
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

UDI: 00724995180256 Serial Numbers: 0032-0822-003
0032-0622-009
0032-0922-001
0032-0822-001
and 0032-0082-002

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Steris Corporation

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