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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

620

Class I (Serious)

Most Recent

Dec 2025

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 801–820 of 10937 recalls

Medtronic Recharger Kits (Medtronic) – Charging Session Issue (2024)

The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

FDASep 18, 2024Nationwide• Medtronic Neuromodulation

Americot Neurological Sponges (American Surgical) – X-Ray Marker Defect (2024)

Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.

FDASep 18, 2024CA, IL, IA +5 more• American Surgical Company, LLC

Quantimetrix Urine Control Set (McKesson) – Packaging Temperature Risk (2024)

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.

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Page 41 of 547Next

FDA

Sep 17, 2024

Nationwide

• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

IMAGEnet 6 Ophthalmic System (Topcon) – Probability Map Error (2024)

The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided

FDASep 17, 2024Nationwide• Topcon Medical Systems, Inc.

Cartesion Prime PET-CT (Canon) – Reconstruction Software Problem (2024)

Laceration Risk

When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.

FDASep 17, 2024AL, AZ, AR +15 more• Canon Medical System, USA, INC.

LINK Universal Handle (Waldemar Link) – Material Failure Risk (2024)

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

FDASep 11, 2024Nationwide• Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany

SynchroMed II Infusion Pump (Medtronic) – Memory Corruption (2024)

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

FDASep 11, 2024Nationwide• Medtronic Neuromodulation

FLUOROspeed (Shimadzu) – Image Display Issue (2024)

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

SONIALVISION G4 (Shimadzu) – Image Display Problem (2024)

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

BK Medical Ultrasound (B-K Medical) – Power Connection Risk (2024)

The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

FDASep 4, 2024Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Leica Biosystems Cryostat (Leica) – Flammable Spray Risk (2024)

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

FDASep 4, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

EVSRF Catheter (Bard) – Wiring Error Risk (2024)

The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.

FDASep 4, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Epikut S Plus CM Implant (SIN) – Diameter Labeling Error (2024)

Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.

FDASep 1, 2024CA, CO, FL +7 more• SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva

Predict+ Tool (Blue Ortho) – Pre-Market Clearance Problem (2024)

Predict+ is being recalled for lack of pre-market clearance/approval.

FDAAug 30, 2024Nationwide• Blue Ortho 22 Chemin Du Vieux Chene Meylan France

Neo-Tee Resuscitator (Mercury) – Manufacturing Step Issue (2024)

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

FDAAug 30, 2024FL, IN, MI +2 more• Mercury Enterprises, Inc. dba Mercury Medical

Monarch Inflation Device (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Melrose Injector (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Monarch Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Hemo-7 Hemospray (Wilson-Cook) – Raw Material Nonconformance (2024)

Specific lots of product have been manufactured with nonconforming raw materials.

FDAAug 29, 2024Nationwide• Wilson-Cook Medical Inc.