Steris recalls CO2MPACT Endoscopic Insufflator systems with specific lot codes due to incorrect tubing material not tested for use. Affected units may pose risks during medical procedures.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Steris is recalling certain CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with untested material. This could lead to safety issues during medical procedures if the device is used improperly.
The internal tubing component was made with incorrect material that wasn't tested for use with the device. This could cause leaks or failures during medical procedures, potentially leading to complications for patients.
Medical professionals using the Steris CO2MPACT Endoscopic Insufflator system for gastrointestinal procedures are most at risk. Patients undergoing these procedures with affected units may be impacted.
Check the lot codes on the device: 93830JEK to 93854JEK, 93899LEK to 93908LEK, or 93909LEK to 93918LEK. The product is designed for use with gastrointestinal endoscopes to inflate the gastrointestinal tract with CO2.
Identify the lot code on the device to determine if it falls within the affected ranges: 93830JEK to 93854JEK, 93899LEK to 93908LEK, or 93909LEK to 93918LEK.
The recalled devices have catalog numbers 72-00310-0 and 710300.
The internal tubing component was made with incorrect material that wasn't tested for use with the device.
Check the lot code on the device; affected units have lot codes 93830JEK to 93854JEK, 93899LEK to 93908LEK, or 93909LEK to 93918LEK.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-1148-2021 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
