Medtronic recalls sterile single-use blades for StraightShot M Series Handpiece and Fusion ENT that have reported tip breaks and wobble/vibration issues.
There was an increase in complaints related to tip breaks and wobble/vibration.
Medtronic is recalling sterile single-use blades used in their StraightShot M Series Handpiece and Fusion ENT systems due to increased complaints about tip breaks and wobble/vibration. This could lead to improper function during dental procedures.
The blades have been reported to break or vibrate during use, which could cause the handpiece to malfunction. This might lead to improper dental procedures or injury if the blade breaks during treatment.
Dentists and dental professionals who use Medtronic StraightShot M Series Handpiece or Fusion ENT Navigation Software systems with the recalled blades. Patients using these systems are at risk if the blades cause improper function during procedures.
Check for product numbers REF 1883080EM, REF 1883480EM, REF 1884006EM, REF 1884012EM, REF 1884080EM, or REF 1884380EM. Also look for specific lot/serial numbers listed in the recall notice.
Identify the blade's product number and lot/serial numbers to confirm if it's recalled.
Reach out to Medtronic for assistance with replacement or return of the recalled blades.
The recall indicates increased complaints about tip breaks and wobble/vibration, so they are not recommended for use until replaced.
Check the product numbers REF 1883080EM, REF 1883480EM, REF 1884006EM, REF 1884012EM, REF 1884080EM, or REF 1884380EM, and the specific lot/serial numbers listed in the recall notice.
No, but you should check if your blades are recalled and contact Medtronic for replacement or return.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0157-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0157-2022 from Medtronic. 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.
