MicroAire recalls SmartRelease Endoscopic System for incorrect sterilization instructions. This affects devices sold from 2013 to 2018. Correct the instructions to prevent infection risks.
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
MicroAire is recalling its SmartRelease Endoscopic System due to incorrect sterilization instructions in the product manual. This could lead to improper sterilization and potential infection risks if users follow outdated guidelines.
The Instructions for Use (IFU) have incorrect sterilization parameters, which could lead to improper sterilization of the device. If the device isn't properly sterilized, it might cause infections during surgical procedures.
Healthcare professionals using the MicroAire SmartRelease Endoscopic System for carpal tunnel release procedures. Patients undergoing this surgery are at risk if the sterilization instructions are followed incorrectly.
Look for the MicroAire SmartRelease Endoscopic System with IFU revision D, sold between January 1, 2013, and February 23, 2018. The device is used for carpal tunnel release procedures.
Review the current Instructions for Use (IFU) to ensure it matches the correct revision. If it's revision D, you may need to update it.
The recall is for healthcare professionals using the device. Patients undergoing the procedure are not directly affected by the recall but should ensure their surgical team follows updated instructions.
You have the recalled product if you own the MicroAire SmartRelease Endoscopic System with IFU revision D, sold between January 1, 2013, and February 23, 2018.
The recall requires updating the Instructions for Use (IFU) to the correct version. There is no need to discard or return the device as the hazard is low risk.
We’ve drafted a message you can send MicroAire to request your refund or repair — edit it as you like.
Subject: Recall Z-2107-2018 — MicroAire MicroAire Hello, I own a MicroAire that is covered by recall Z-2107-2018 from MicroAire. 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.
