Medtronic Sterile single-use blades that are components of the… — Class II medical device recall Z-0158-2022
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-0158-2022 |
|---|---|
| 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 | 00763000033798, 00763000033811, 00763000033835, 00763000033866, 00763000033873, 00763000033880, 00763000033897, 00763000033903, 00763000043193, 00763000043216, 00763000043223 |
| Serial numbers | 0218179458, 0218179459, 0218284087, 0218292178, 0218297618, 0218297619, 0218299192, 0218299193, 0218323602, 0218973633, 0220002825, 0220226674, 0220443669 |
| Model numbers | 40A2500, 40R2000, 40R2500, 40S2000, 40S2500, 45A2000, 45A2500, 45R2000, 45R2500, 45S2000, 45S2500 |
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 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.
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-0158-2022. 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.