Medtronic sterile single-use blades that are components of the… — Class II medical device recall Z-0157-2022
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 number | Z-0157-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2021-08-31 |
| Classified | 2021-10-21 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, 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 |
| Quantity | 274,991 devices |
| UPC / GTIN / UDI-DI | 00763000033842, 00763000034009, 00763000034016, 00763000034023, 00763000043247, 00763000043254 |
| Serial numbers | 0217258057, 0217258058, 0217258059, 0217258060, 0217258061, 0217258062, 0217258063, 0217258064, 0217258065, 0217260946, 0217260947, 0217260948, 0217260949, 0217260950, 0217260951, 0217260952, 0217260953, 0217260954, 0217260955, 0217260956, 0217260957, 0217260958, 0217260959, 0217262726, 0217667211 and 264 more |
| Model numbers | 1883080EM, 1883480EM, 1884006EM, 1884012EM, 1884080EM, 1884380EM |
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 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.
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-0157-2022. 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.