Drugs & medicalClass II

Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes…

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

Read the official notice →
Date
2024-10-30
Country
United States
Brand
Blue Ortho
Product
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes…
Classification
Class II
Units
US Nationwide distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

Other drugs & medical recalls in the United States

  1. 2024-10-30
  2. US
    Drugs & medicalClass II

    Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recalls A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the…

    The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may…

    FDA · DevicePolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Japan, South Africa.Official notice →
  3. US
    Drugs & medicalClass II

    Ad-Tech Medical Instrument Corporation recalls AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

    Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol.…

    FDA · DeviceAd-Tech Medical Instrument CorporationUS Nationwide distribution in the states of CA, OH.Official notice →
  4. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083

    The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.

    FDA · DeviceBaxter Healthcare CorporationWorldwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Diasol, Inc recalls Diasol Acid Concentrate REF G100325-10Dex 100

    Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.

    FDA · DeviceDiasol, IncU.S. Nationwide distribution in the state of AZ.Official notice →
  6. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.

    FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Germany, UK, and Israel.Official notice →
  7. US
    Drugs & medicalClass II

    Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable…

    FDA · DeviceSmiths Medical ASD, Inc.Worldwide distribution.Official notice →
See all drugs & medical recalls →