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Medtronic Xomed, Inc.

Medtronic Xomed, Inc. Recalls

All product recalls associated with Medtronic Xomed, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4941–4960 of 37665 recalls

NIM TriVantage EMG Tube (Medtronic) – Monitoring Issues (2023)

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

High

FDANov 7, 2023Nationwide• Medtronic Xomed, Inc.

Peterbilt 520 (Peterbilt) – Engine Bracket (2023)

PACCAR Incorporated (PACCAR) is recalling certain 2024 Peterbilt 520 vehicles. The rear lifting bracket that attaches to the engine cylinder head may be insufficiently secured, which can allow it to detach.

High

NHTSANov 7, 2023Nationwide• PETERBILT

Spartan Fire MetroStar (Spartan) – Parking Brake (2023)

Fire/Burn Risk

Custom Fire Apparatus, Inc (Custom Fire) is recalling certain 2021-2024 Spartan Gladiator, MetroStar, and FC-94 emergency vehicles. A defect in the inversion valve may delay the park brake setting after engagement, which could allow the vehicle to move unintentionally.

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High

NHTSANov 7, 2023Nationwide• SPARTAN FIRE

Medical System (GE) – Bolt Torque Issue (2023)

GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

High

FDANov 7, 2023Nationwide• GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China

CARDIOHELP-i System (Maquet) – Factory Settings (2023)

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Moderate

FDANov 6, 2023Nationwide• Maquet Medical Systems USA

Fountain Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

SEROLOGY ToRCH lgM (Randox) – reactivity decrease (2023)

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

Moderate

FDANov 6, 2023NY, WV• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Sprite (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

Hydrocortisone Acetic Acid Otic Solution (Taro) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class IIILow

FDANov 6, 2023Nationwide• Taro Pharmaceuticals Inc.

Vitrakvi Oral Solution (Bayer) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Class IHigh

FDANov 6, 2023Nationwide• Bayer Healthcare Pharmaceuticals Inc.

ENDOEYE HD II Videoscope (Olympus) – image coloration (2023)

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

Moderate

FDANov 6, 2023Nationwide• Olympus Corporation of the Americas

Fanta Orange (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Moderate

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Diet Coke (United Packers) – foreign material (2023)

Potential foreign material

Class IIModerate

FDANov 6, 2023AL, FL, MS• United Packers, LLC

Sterile PVP Solution (Medline) – non-sterile contents (2023)

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

High

FDANov 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Allura Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Medical Drainage Bag (Remington) – label date error (2023)

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

Low

FDANov 3, 2023FL, PA• Remington Medical, Inc.

Sterile Betadine (Medline) – non-sterile contents (2023)

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

High

FDANov 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Model S (Tesla) – incorrect airbag installation (2023)

Tesla, Inc. (Tesla) is recalling certain 2021-2024 Model S and Model X vehicles. An incorrect air bag may have been installed when the steering yoke or round steering wheel was replaced with a different style of yoke or steering wheel.

High

NHTSANov 3, 2023Nationwide• TESLA