The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

42601–42625 of 50511

  • HighFDA (Devices)·Z-0125-2014·2013-11-06

    Medtronic Activa Deep Brain Stimulators Recalled for Potential Overstimulation

    Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.

    Product
    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.

    Product
    Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2014·2013-11-06

    Globus Medical Recalls MicroFuse Putty Due to Sterility Assurance Concerns

    Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.

    Product
    Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.

    Product
    Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2014·2013-11-06

    GE Centricity PACS-IW Software Recall for Patient Safety Risks

    GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.

    Product
    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0039-2014·2013-11-06

    Xoran Minicat CT Scanners Recalled for Dose Rate Failures

    Xoran Technologies is recalling Minicat CT Scanners that failed to meet specifications for dose rate, potentially affecting patient safety.

    Product
    Xoran Minicat00158
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2014·2013-11-06

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2014·2013-11-06

    Xoran MiniCAT CT Scanner Recalled for Gantry Rotation Failure

    Xoran Technologies is recalling 320 MiniCAT CT Scanners because the gantry may fail to rotate while emitting radiation.

    Product
    Xoran MiniCAT CT Scanner ID ENT00001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2014·2013-11-06

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0082-2014·2013-11-06

    Amport Foods Chocolate Raisins Recalled for Peanut Mislabeling

    American Importing Co, Inc. is recalling Amport Foods Chocolate Raisins because a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins.

    Product
    Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0121-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.

    Product
    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating Risk

    Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.

    Product
    Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2014·2013-11-06

    bioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues

    bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.

    Product
    chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2014·2013-11-06

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Stimulation Issues

    Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2014·2013-11-06

    Xoran Mini CT Scanner Recalled for Dose Rate Specification Failures

    Xoran Technologies is recalling 320 Mini CT Scanners because they failed to meet internal specifications for dose rate, with complaints indicating rates both high and low.

    Product
    Xoran Mini CT Scanner
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2014·2013-11-06

    Breeze C Electric Scooter Recalled for Electrical Contact Fault

    S.A.E. Afikim is recalling 69 Breeze C electric scooters because an electrical contact may fail, potentially preventing the driver from stopping the vehicle.

    Product
    Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2014·2013-11-06

    Zimmer Recalls NexGen CR-Flex Tibial Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen CR-Flex Mobile Bearing Tibial Components because the packaging bags adhere to the device surfaces.

    Product
    NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2014·2013-11-06

    Fujinon Ultrasonic Endoscope Recall for Missing Set Screws

    Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.

    Product
    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2014·2013-11-06

    Carestream DRX-Revolution Mobile X-ray System Recalled for Sparking Power Plug

    Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.

    Product
    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0087-2014·2013-11-06

    Pringles Salt and Vinegar Chips Recalled for Undeclared Milk Allergen

    Kellogg Canada is recalling Pringles Salt and Vinegar Potato Chips because the packaging failed to declare milk as an ingredient, violating Canadian labeling regulations.

    Product
    Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072
    Category
    Food
    Distribution
    0 states