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Medtronic Neuromodulation

Medtronic Neuromodulation Recalls

All product recalls associated with Medtronic Neuromodulation.

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Recall Summary

Total Recalls

1000

Past Year

893

Class I (Serious)

124

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 2641–2660 of 17593 recalls

A901 Communication Manager (Medtronic) – Software Compatibility (2023)

When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.

Low

FDAJun 21, 2023Nationwide• Medtronic Neuromodulation

Liquid Urine Control (Randox) – Test Result Variation (2023)

(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.

Moderate

FDAJun 21, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Level-1 Protein (1st Phorm) – Bacterial contamination (2023)

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Product may contain Staphylococcus aureus.

Class IIModerate

FDAJun 21, 2023MO• International Food Companies DBA International Food Products

Tampico Mango Punch (Garelick Farms) – Undeclared color (2023)

Undeclared Allergen

Product contains undeclared Yellow 5.

Class IIModerate

FDAJun 21, 2023CT, MA, NH +3 more• Garelick Farms LLC

Organic Tropical Fruit Blend (Trader Joe's) – Listeria risk (2023)

Listeria

Potential for contamination with Listeria monocytogenes. Pineapples are recalled by supplier Sunrise Growers Inc.

Class IHigh

FDAJun 21, 2023Nationwide• Scenic Fruit Company, LLC

Organic Pineapple Frozen Fruit (Cadia) – Listeria risk (2023)

Listeria

Potential for contamination with Listeria monocytogenes. Pineapples are recalled by supplier Sunrise Growers Inc.

Class IHigh

FDAJun 21, 2023Nationwide• Scenic Fruit Company, LLC

Ringed DxI Reaction Vessels (Beckman Coulter) – System Compatibility (2023)

Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

Moderate

FDAJun 20, 2023Nationwide• Beckman Coulter, Inc.

ProPlan CMF Guide (Materialise) – Incorrect Guide Versions (2023)

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Moderate

FDAJun 19, 2023Nationwide• Materialise N.V. Technologielaan 15 Heverlee Belgium

Hip Screw (Conformis) – Incorrect Length Labeling (2023)

30mm screws were labeled as 25mm screws.

Moderate

FDAJun 16, 2023Nationwide• Conformis, Inc.

Romaine Lettuce (C&E Farms) – Deer Droppings Contamination (2023)

Product possibly contaminated with deer droppings

Class IIModerate

FDAJun 16, 2023MA, MN• C&E Farms, Inc.

Smoked Salmon Spread (Kenai Red Fish) – Allergen Mislabeling (2023)

The ingredients Statement declares Salmon, Marscapone, Cream Cheese, and Worchester Sauce. The Contains statement declares Fish and Milk but it does not declare Anchovies and Salmon.

Class IIILow

FDAJun 14, 2023IN, OR• Kenai Red Fish Company LLC

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

Original Eye Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Dry Eye Relief Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Ranch Salad Dressing (Tony Charchere's) – Product Spoilage (2023)

Bubbling of product and sour taste

Class IIILow

FDAJun 13, 2023IN, LA• SCREAMING EAGLE CO PACK LLC

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

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

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

EVIS EXERA III Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope BF Type (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas