CLASS II ONGOING Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
Medtronic Sterile single-use blades that are components recalled
Medtronic Xomed is recalling Medtronic Sterile single-use blades that are components of the StraightShot M Series, distributed nationwide in the US. The recall was initiated on 31 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0158-2022
- FDA event ID
- 88586
- Recalling firm
- Medtronic Xomed, Jacksonville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2021
- FDA classified
- 21 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 31 Aug 2021 | Recall initiated by company | |
| 21 Oct 2021 | Classified by FDA | +51 days |
| 27 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There was an increase in complaints related to tip breaks and wobble/vibration.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
There was an increase in complaints related to tip breaks and wobble/vibration.
Which lots are affected?
(1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825; (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458; (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192; (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459; (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674; (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669; (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602; (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633; (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618; (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193; (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88586| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic sterile single-use blades that are components recalled | Medtronic Xomed | Device Malfunction | Nationwide | |
| CLASS II | Medtronic sterile single-use blades that are components recalled | Medtronic Xomed | Device Malfunction | Nationwide |
More recalls from Medtronic Xomed
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IPC Powerease System recalled by Medtronic Xomed | Medtronic Xomed | Other | 25 states |
| Device | CLASS II | NIM Vital Nerve Monitoring System: Console NIM4CM01 NIM recalled | Medtronic Xomed | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic ENT Ultra Round Steel Cutting Bur recalled by Medtronic Xomed | Medtronic Xomed | Other | FL |
| Device | CLASS II | NIM TriVantage EMG Endotracheal Tubes recalled by Medtronic Xomed | Medtronic Xomed | Other | FL |
| Device | CLASS I | NIM EMG Endotracheal Tube, Part Numbers: a) recalled by Medtronic Xomed | Medtronic Xomed | Other | Nationwide |
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