Medtronic Xomed, Inc. recalls IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and…
Due to out of the box wobble of the driver.
Read the official notice →- Date
- 2025-09-03
- Country
- United States
- Brand
- Medtronic Xomed
- Product
- IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and…
- Classification
- Class II
- Units
- U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-04-30
USMedtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;…
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
FDA · DeviceMedtronic Xomed, Inc.Worldwide - US Nationwide distribution including in the states of MD, MN, PA,…Official notice →- 2024-09-18
- US
Medtronic Xomed, Inc. recalls Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Product was distributed past expiration date.
FDA · DeviceMedtronic Xomed, Inc.International distribution to the country of Canada.Official notice → - 2024-07-31
- US
Medtronic 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 →
Other drugs & medical recalls in the United States
- 2025-09-03
- US
American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL…
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS…
- US
Zhejiang Luyao Electronics Technology Co., Ltd. recalls Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product…
Regulatory documentation error and misleading color packaging claim.
FDA · DeviceZhejiang Luyao Electronics Technology Co., Ltd.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - US
C.R. Bard Inc recalls Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep…
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney…
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH,…
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
- US
BD SWITZERLAND SARL recalls BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF:…
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
FDA · DeviceBD SWITZERLAND SARLUS Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing…
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution tin the states of CA, FL, IA, and TX.Official notice →