The Recall Desk

Hazard

Mri Safety recalls

21 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
21
Critical
0
Severe
3
Most recent
2024-10-30

Of the 21 mri safety recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (14%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mri safety recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–21 of 21

  • HighFDA (Devices)·Z-0220-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy

    Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2473-2024·2024-08-14

    MR System Software Defect May Cause Implant Overheating During Scanning

    GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.

    Product
    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2022·2022-03-09

    Titanium Toe Joint Implant Contains False MR Compatibility Claims

    BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Statements

    BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2022·2022-03-09

    Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims

    BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2022·2022-03-09

    Titanium MPJ Toe Implant Recalled for Incorrect MR Safety Labeling

    BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2020·2020-01-01

    Cordis Precise Nitinol Stent System Labeling Correction for MRI Information

    Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.

    Product
    Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid ni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0036-2020·2019-10-09

    Quality Electrodynamics Recalls MRI Knee Coils Due to Ferrous Material Risk

    Quality Electrodynamics LLC is recalling 36 Siemens MRI knee coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0037-2020·2019-10-09

    Quality Electrodynamics Recalls Siemens Knee and Extremity MRI Coils

    Quality Electrodynamics LLC is recalling 21 Siemens MRI coils due to potential ferrous material in the pushbutton assembly.

    Product
    TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0034-2020·2019-10-09

    Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0033-2020·2019-10-09

    Quality Electrodynamics Recalls MRI Extremity Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling five Siemens MRI extremity coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2408-2019·2019-09-04

    Ad-Tech Skull Anchor Bolts Recalled for Incorrect MRI Approval Labeling

    Ad-Tech Medical Instrument Corporation is recalling Skull Anchor Bolts because supplemental information incorrectly indicated they were approved for use in the MR environment.

    Product
    Skull Anchor Bolts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2015·2015-09-30

    Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling

    Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.

    Product
    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2015·2015-09-02

    Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections

    Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.

    Product
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2015·2015-02-04

    Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling

    Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.

    Product
    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1816-2013·2013-08-07

    Synthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert

    Synthes USA HQ, Inc. is recalling 8 units of Large External Fixation Tube to Tube Clamps because the provided insert incorrectly states the device is MR Safe instead of MR Conditional.

    Product
    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
    Category
    Medical Device
    Distribution
    4 states