Medtronic Xomed, Inc.
Complete recall history across all FDA and CPSC categories — 26 total recalls
Medtronic Xomed, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (26)
FDA medical device enforcement actions by Medtronic Xomed, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 17, 2025 | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. ... | Due to out of the box wobble of the driver. | Class II |
| Mar 10, 2025 | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; ... | Nerve Monitoring System with certain software versions has potential for incr... | Class II |
| Jul 5, 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Class II |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I |
| Nov 7, 2023 | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822... | Firm received reports of customers experiencing noise from the NIM System, le... | Class II |
| May 3, 2022 | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II |
| May 3, 2022 | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... | The firm received reports of events related to airway obstruction while using... | Class I |
| Apr 29, 2022 | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... | The firm received reports of events related to airway obstruction while using... | Class I |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... | The firm received reports of events related to airway obstruction while using... | Class I |
| Dec 22, 2021 | NIM TRIVANTAGE EMG Endotracheal Tube | There is potential for multiple issues due to a manufacturing nonconformity. | Class II |
| Dec 15, 2021 | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... | As a result of Medtronic's integrated power console (authentication number: 2... | Class II |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II |
| Aug 31, 2021 | Medtronic sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II |
| Aug 31, 2021 | Medtronic Sterile single-use blades that are components of the StraightShot M... | There was an increase in complaints related to tip breaks and wobble/vibration. | Class II |
| Jun 12, 2020 | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind... | During internal testing execution of the next generation of Integrated Power ... | Class II |
| Nov 13, 2019 | Lamicel 20PK 3MM INTL Cervical dilator | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II |
| Nov 13, 2019 | Lamicel 20PK 5MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II |
| Nov 13, 2019 | Lamicel 10PK 10MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II |
| Jun 28, 2016 | NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St... | Wire in tubing can become exposed, posing potential harm to the intubated pat... | Class II |
| Aug 23, 2013 | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... | One lot of the product was assembled using the Cam Head version of the same p... | Class II |
| Jul 9, 2013 | Tray Surgical, ENT (various instrument trays) Used for stot age and transp... | The firm will recall and replace the identified instrument trays in the field... | Class II |
| Mar 4, 2013 | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotrache... | Class I |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Inter... | Class II |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Inter... | Class II |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Inter... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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