Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
There was an increase in complaints related to tip breaks and wobble/vibration.
Read the official notice →- Date
- 2021-10-27
- Country
- United States
- Brand
- Medtronic Xomed
- Product
- Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide, including PR. There was also…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Xomed recalls
- 2024-07-31
USMedtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM…
Potential for false negative response on the NIM Vital Nerve Monitoring System
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice →- 2024-01-17
- US
Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d)…
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- 2022-09-07
- US
Medtronic Xomed, Inc. recalls NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2022-06-08
- US
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide distribution in the states of TX, CO,…Official notice → - 2022-04-27
- US
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between…
- 2022-03-16
- US
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
There is potential for multiple issues due to a manufacturing nonconformity.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-27
- US
DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
FDA · DeviceDiaSorin Molecular LLCWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
Kinsman Enterprises Inc recalls Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
The belt may fail at lower loads than the labeled 600lbs.
FDA · DeviceKinsman Enterprises IncDistribution in CA, FL, GA, IL, KY, MI, MS, NC, NH, NJ, NY, OH, TN, VAOfficial notice → - US
Limacorporate S.p.A recalls REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
FDA · DeviceLimacorporate S.p.AWorldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice → - US
Smiths Medical ASD Inc. recalls medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE…
Product has a lack of sterility assurance
FDA · DeviceSmiths Medical ASD Inc.International Distribution to countries of: Armenia, Austria, Germany, Great…Official notice → - US
Bard Peripheral Vascular Inc recalls Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G…
Due to misbranded products shipped to customers.
FDA · DeviceBard Peripheral Vascular IncU.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA,…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical portex Loss of Resistance Device, REF 100/398/000
The labeling was missing information on sterilization and prohibition of reuse.
FDA · DeviceSmiths Medical ASD Inc.Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France,…Official notice →