Data Foundry

Medical device recalls 2021

Medtronic sterile single-use blades that are components of the… — Class II medical device recall Z-0156-2022

Ongoing recall by Medtronic Xomed, Inc., reported 2021-10-27, distributed nationwide. There was an increase in complaints related to tip breaks and wobble/vibration.

Recall numberZ-0156-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Xomed, Inc., Jacksonville, FL, United States
Recall initiated2021-08-31
Classified2021-10-21
Reported by FDA2021-10-27
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, BH, CA, CH, CL, CZ, DE, DK, DO, EE, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IN, IR, IS, IT, JM, JP, KE, KR, KW, LK, LU, LV, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, UA, VN, ZA
Quantity274,991 devices
UPC / GTIN / UDI-DI00763000033552, 00763000033910, 00763000033989, 00763000033996, 00763000036140, 00763000036447, 00763000036713, 00763000036720, 00763000036737, 00763000036744, 00763000036751, 00763000036768, 00763000036775, 00763000036782, 00763000036799, 00763000036805, 00763000037369, 00763000037376, 00763000037383, 20763000038162, 20763000040301, 20763000040967, 20763000041223, 20763000041230
Serial numbers0217261083, 0217261084, 0217261085, 0217261579, 0217261580, 0217261581, 0217261582, 0217663791, 0217663792, 0217663793, 0217663794, 0217663795, 0217663796, 0217665427, 0217665428, 0217665429, 0217666173, 0217666174, 0217666175, 0217666176, 0217666177, 0217666178, 0217666179, 0217666180, 0217666181 and 341 more
Model numbers1882902HRE, 1882905HRE, 1882916, 1882924HRE, 1882936E, 1882937E, 1882979HRE, 1883080HRE, 1883480HRE, 1883502HRE, 1883506HRE, 1883512HRE, 1883514, 1883516HRE, 1884005HRE, 1884013, 1884020, 1884030HRE, 1884031HRE, 1884032, 1884033, 1884033HRE, 1884380HR, 1884380HRE

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0156-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.