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Medtronic Neurosurgery

Medtronic Neurosurgery Recalls

All product recalls associated with Medtronic Neurosurgery.

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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 5901–5920 of 37665 recalls

Durepair Dura Matrix (Medtronic) – Endotoxin Level Concern (2023)

Laceration Risk

Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

Moderate

FDAJun 13, 2023Nationwide• Medtronic Neurosurgery

RX Series Urea Enzymatic Assay (Randox) – Carryover Bias (2023)

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

Moderate

FDAJun 13, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Ingenia Elition S MR System (Philips) – Smoke Detector Bypass (2023)

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The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Bypass (2023)

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

Ingenia Elition S MR System (Philips) – Smoke Detector Cable Issue (2023)

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

da Vinci Grasper (Intuitive Surgical) – Grip Breakage Risk (2023)

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Moderate

FDAJun 12, 2023Nationwide• Intuitive Surgical, Inc.

Allura Xper X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

Moderate

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

AEQUALIS FLEX REVIVE Screw (Tornier) – Labeling Mix-up (2023)

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Low

FDAJun 12, 2023Nationwide• Tornier, Inc

Azurion 7 X-ray System (Philips) – FlexMove Carriage Defect (2023)

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

Moderate

FDAJun 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Ingenia Elition X MR System (Philips) – Smoke Detector Cable Issue (2023)

Moderate

FDAJun 12, 2023Nationwide• Philips North America

Ingenia Elition X MR System (Philips) – Smoke Detector Bypass (2023)

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

Mini Fruit Jelly Cup (Pamana) – Choking Hazard (2023)

Choking Hazard

Potential choking hazard

Class IHigh

FDAJun 12, 2023Nationwide• Foremost Foods International, Inc.

Beetroot Powder (Havasu) – Undeclared Milk (2023)

Undeclared Milk

Contains undeclared milk

Class IIModerate

FDAJun 12, 2023Nationwide• Supplement Manufacturing Partner, Inc.

Mini Fruit Jelly Cup (Pamana) – Choking Hazard (2023)

Choking Hazard

Potential choking hazard

Class IHigh

FDAJun 12, 2023Nationwide• Foremost Foods International, Inc.

Berry Burst Slab Cake (Wow Factor) – Norovirus Risk (2023)

Possible norovirus contamination

Class IIModerate

FDAJun 12, 2023CO, IN, MI +2 more• Wow Factor Desserts

Mini Fruit Jelly Cup (Pamana) – Choking Hazard (2023)

Choking Hazard

Potential choking hazard

Class IHigh

FDAJun 12, 2023Nationwide• Foremost Foods International, Inc.

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

Moderate

FDAJun 12, 2023Nationwide• Philips North America

Apple Juice (Martinelli's) – Glass Quality Issue (2023)

Potential glass quality issue that may result in glass chips in the product

Class IIModerate

FDAJun 12, 2023CA, IN, NY +1 more• S. Martinelli Harvest Facility

Sterile Ultrasound Gel (Turkuaz) – Sterility Concern (2023)

Sterility of Ultrasound gel can not be guaranteed.

Moderate

FDAJun 9, 2023IL• Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey

DEKA Car Battery (East Penn Manufacturing) – Electrical Connection Issue (2023)

East Penn Manufacturing Company, Inc. (East Penn) is recalling certain Deka batteries, model 648MF. The electrical connection between the internal battery cell and external terminal may be incomplete, which can cause an electrical spark.

Moderate

NHTSAJun 9, 2023Nationwide• EAST PENN MANUFACTURING