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.

41951–41975 of 50511

  • HighFDA (Drugs)·D-921-2014·2014-01-29

    FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.

    Product
    LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134401.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-787-2014·2014-01-29

    Aidapak Recalls Calcitriol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Calcitriol 0.25 mcg capsules because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054000725.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0807-2014·2014-01-29

    GE Healthcare Patient Data Module Recall for ECG Noise

    GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2014·2014-01-29

    Radiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias

    Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium results.

    Product
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0797-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

    Product
    DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-965-2014·2014-01-29

    Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling guanfacine HCl tablets because they may have been mislabeled as other prescription drugs.

    Product
    guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0787-2014·2014-01-29

    Siemens Linac Treatment Table Recall for Finger Pinch and Cable Damage

    Siemens is recalling 305 linear accelerator treatment tables due to risks of finger pinching and cable short-circuits.

    Product
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1003-2014·2014-01-29

    Aidapak Recalls Amantadine HCL Capsules Due to Labeling Mixup

    Aidapak Services is recalling Amantadine HCL capsules because they may have been mislabeled as other prescription drugs.

    Product
    AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0790-2014·2014-01-29

    BD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing

    Becton Dickinson is recalling 33 kits of the BD GeneOhm Cdiff Assay because an incorrect reagent was packed, which may cause false negative results for C. difficile.

    Product
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0809-2014·2014-01-29

    CryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns

    CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.

    Product
    Pulmonary Hemi-Artery SG Used in heart surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0798-2014·2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 diagnostic x-ray systems due to a potential for unexpected device movement.

    Product
    DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2014·2014-01-29

    Sorin Orchestra Programmer Overestimates Pacemaker Battery Life

    Sorin Group Italia is notifying physicians that its Orchestra programmer may overestimate the residual longevity of specific implanted pacemakers.

    Product
    ORCHESTRA/ORCHESTRA PLUS Programmer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-756-2014·2014-01-29

    Theraflu Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances

    Novartis Consumer Health is recalling Theraflu Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.

    Product
    Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2014·2014-01-29

    Philips Recalls ADAC Gamma Camera Systems Due to Fork Joint Crack Risk

    Philips Medical Systems is recalling ADAC ARGUS and CIRRUS Gamma Camera Systems because routine maintenance may fail to detect small cracks in the fork weldments.

    Product
    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2014·2014-01-29

    GE Healthcare Recalls TRAM Modules Due to Intermittent ECG Noise

    GE Healthcare is recalling 1,948 TRAM Modules because movement of the ECG cable connector causes intermittent noise on ECG and respiration waveforms, potentially reducing monitoring performance.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-957-2014·2014-01-29

    Liothyronine Sodium Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Liothyronine Sodium 25 mcg tablets because they may have been mislabeled as Levothyroxine Sodium or Hyoscyamine Sulfate.

    Product
    LIOTHYRONINE SODIUM, Tablet, 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574022201.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1007-2014·2014-01-29

    FDA Recalls Mislabeled Tacrolimus Capsules Distributed by Aidapak Services

    Aidapak Services is recalling 1 mg tacrolimus capsules that may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0782-2014·2014-01-29

    Ranir Recalls UP & UP Kids' Power Toothbrushes Due to Choking Hazard

    Ranir is recalling UP & UP and TopCare kids' power toothbrushes because the tufted disk may detach, posing a choking hazard to children three and younger.

    Product
    UP & UP kids' power toothbrush
    Category
    Consumer Product
    Distribution
    2 states
  • HighFDA (Drugs)·D-770-2014·2014-01-29

    Entecavir Tablets Recalled Due to Potential Label Mixup

    Aidapak Services is recalling Entecavir tablets because they may be mislabeled as other prescription drugs.

    Product
    ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00003161112.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0810-2014·2014-01-29

    Medrad Recalls Veris MR Monitor Units Due to Faulty Main Board

    Medrad is recalling 922 Veris MR Monitor units because a faulty main board may cause unexpected system shutdowns, resulting in the loss of vital signs information.

    Product
    Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-822-2014·2014-01-29

    Venlafaxine HCL Tablets Recalled for Potential Labeling Errors

    Aidapak Services, LLC is recalling Venlafaxine HCL 25 mg tablets because they may have been mislabeled as other prescription drugs.

    Product
    VENLAFAXINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093019901.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0823-2014·2014-01-29

    Siemens CentraLink Software Recall for Potential Patient Data Release Error

    Siemens is recalling CentraLink Data Management System software versions 14.0.4, 14.0.5, and 14.0.8 because a disabled patient result may be released without proper review.

    Product
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0786-2014·2014-01-29

    Siemens Recalls SimView NT Radiation Therapy Simulation Systems

    Siemens is recalling 65 SimView NT radiation therapy simulation systems worldwide because a rare mechanical failure could prevent the stopping of intended component movements.

    Product
    SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-751-2014·2014-01-29

    Novartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence

    Novartis is recalling Theraflu and related cold medicine powder packets because they may contain foreign substances. The recall affects products distributed in the US, Canada, Mexico, and other countries.

    Product
    Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide