# FDA recall Z-0156-2022

> **Medtronic Xomed, Inc.** · Class II · device recall initiated 2021-08-31.

## Product

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) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm;  (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm;  (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm;  (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm;  (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm;  (6) REF 1884033, Tracheal Blade, Angle Tip;  (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable;  (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable;  (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable;  (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm;  (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm;  (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable;  (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable;  (14) REF 1883480HR

## Reason for recall

There was an increase in complaints related to tip breaks and wobble/vibration.

## Distribution

Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.

## Key facts

- **Recall number:** Z-0156-2022
- **Recalling firm:** Medtronic Xomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-31
- **Report date:** 2021-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jacksonville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0156-2022

## Citation

> AI Analytics. FDA recall Z-0156-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0156-2022. Source: US FDA. Licensed CC0.

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