FDA Device recall Z-0156-2022
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the… by Medtronic Xomed, citing there was an increase in complaints related to tip breaks and wobble/vibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0156-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-31 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Xomed |
| Distribution | US |
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 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.
Reason
There was an increase in complaints related to tip breaks and wobble/vibration.
Identifiers
| code_info | (1) REF 1882916, GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715, 0218283722, 0218283942, 0218356873, 021835687…(1) REF 1882916, GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715, 0218283722, 0218283942, 0218356873, 0218356874, 0218356875, 0218623544, 0219369113, 0219501397, 0219700166, 0220118673, 0220659645, 0220784922, 0220826101, 0220826102, 0221020300, 0221118606, 0221118607, 0221118608, 0221198946, 0221198951, 0221198952, 0221430166, 0221489935, 0221611652, 0221791819, 0221791821; (2) REF 1883514, GTIN/UPN 20763000040967 - Lot/serial numbers 0218283532, 0218791333, 0219215919; (3) REF 1884013, GTIN/UPN 20763000041230 - Lot/serial numbers 0217969616, 0217969617, 0218283944, 0218572177, 0219010745, 0219110914, 0221170726, 0221603993, 0221783424, 0221791809; (4) REF 1884020, GTIN/UPN 20763000040301 - Lot/serial numbers 0219501396, 0220648062, 0220649166, 0220892207, 0221156835, 0221271500; (5) REF 1884032, GTIN/UPN 00763000036140 - Lot/serial numbers 0220057395, 0220057397; (6) REF 1884033, GTIN/UPN 00763000036447 - Lot/serial numbers 0220057389, 0220057390, 0220057392; (7) REF 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0156-2022%22
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