Reported Oct 27, 2021 · Ongoing
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
24 of 24 products
| Model / number | Product as published |
|---|---|
1882916 | Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) , RAD 60 Sinus Blade, 11 cm x 2.9 mm |
1883514 | (2) , RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm |
1884013 | (3) , Powered Tonsillectomy Blade, 11 cm x 4 mm |
1884020 | (4) , Tricut Laryngeal Blade, 22.5 cm x 4 mm |
1884032 | (5) , Tracheal Blade, 37 cm x 4 mm |
1884033 | (6) , Tracheal Blade, Angle Tip |
1882902HRE | (7) , Serrated Blade, 11 cm X 2.9 mm, Rotatable |
1882905HRE | (8) , Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable |
1882924HRE | (9) , Skimmer Blade, 27 cm x 2.9 mm, Rotatable |
1882936E | (10) , Angle-Tip Serrated Blade, 18 cm x 2.9 mm |
1882937E | (11) , Angle-Tip Serrated Blade, 22 cm x 2.9 mm |
1882979HRE | (12) , Skimmer Blade, 13 cm x 2.9 mm, Rotatable |
1883080HRE | (13) , Quadcut Blade, 3.0 mm, Rotatable |
1883480HRE | (14) , Quadcut Blade, 3.4 mm, Rotatable |
1883502HRE | (15) , Serrated Blade, 11 cm x 3.5 mm, Rotatable |
1883506HRE | (16) , RAD 40 Blades, 11 cm x 3.5 mm, Rotatable |
1883512HRE | (17) , RAD 12 Blade, 11 cm x 3.5 mm, Rotatable |
1883516HRE | (18) , RAD 60 Blade, 11 cm x 3.5 mm, Rotatable |
1884005HRE | (19) , Silver Bullet Blade, 11 cm x 4 mm, Rotatable |
1884030HRE | (20) , Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable |
- Amount recalled
- 274,991 total devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
There was an increase in complaints related to tip breaks and wobble/vibration.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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