The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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25376–25400 of 27686

  • HighFDA (Devices)·Z-1075-2014·2014-03-05

    Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results

    Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.

    Product
    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect

    Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.

    Product
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1106-2014·2014-03-05

    Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2014·2014-03-05

    Siemens Artis zee Ceiling Systems Recalled for Cable Damage Risk

    Siemens Medical Solutions USA is recalling 284 Artis zee Ceiling Systems due to potential cable damage from sub-optimal guidance.

    Product
    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2014·2014-03-05

    Fresenius Optiflux F200NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 19,596 Optiflux F200NR dialyzers due to a dialysate port leak during priming. The units were distributed in the US and Mexico.

    Product
    Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0980-2014·2014-02-26

    Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter

    Merit Medical Systems is recalling custom procedural trays containing 1% Lidocaine HCl injection due to visible particulate matter found in the product container.

    Product
    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0995-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2014·2014-02-26

    Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error

    Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.

    Product
    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0999-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1000-2014·2014-02-26

    Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2014·2014-02-26

    Standing Company Recalls Superstand Wheelchairs Due to Flex Shaft Fracture Risk

    The Standing Company is recalling approximately 119 Superstand stand-up wheelchairs because the flex shaft may fracture if bent repeatedly or beyond 90 degrees.

    Product
    Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2014·2014-02-26

    Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error

    Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.

    Product
    Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2014·2014-02-26

    GE Healthcare Recalls Dash Patient Monitors Due to Network and ECG Issues

    GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors and Dash Port 2 Docking Stations due to network communication failures and distorted ECG waveforms.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2014·2014-02-26

    Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.

    Product
    Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2014·2014-02-26

    Elekta Synergy XVI Radiation Therapy System Recalled for Collision Risk

    Elekta, Inc. is recalling 312 Synergy XVI radiation therapy systems due to a potential collision risk when used with external beam shaping devices.

    Product
    Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2014·2014-02-26

    B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage

    B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.

    Product
    SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2014·2014-02-26

    GE Healthcare Recalls PET Discovery Systems Due to Scatter Overcorrection

    GE Healthcare is recalling PET Discovery 600, 610, 690, and 710 systems due to a potential safety issue with the List Mode Replay feature causing scatter overcorrection.

    Product
    GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy…
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1030-2014·2014-02-26

    Zimmer Recalls ZIMTRON 6 DEG 22 Heads Due to Packaging Validation Issues

    Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    ZIMTRON 6 DEG 22 HEADS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2014·2014-02-26

    Biosense Webster Recalls CartoUnivu Module for Map Misalignment

    Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.

    Product
    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1026-2014·2014-02-26

    Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues

    Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    HGP II ACETABULAR CUP MOD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2014·2014-02-26

    Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles

    Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.

    Product
    Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2014·2014-02-26

    Siemens Prisma 2K Pediatric Hearing Aid Battery Compartment Recall

    Siemens is recalling Prisma 2K hearing aids because the battery compartment may open under unintended use, posing a risk to infants and children.

    Product
    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2014·2014-02-26

    Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting

    Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.

    Product
    Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or beveled tip with or without flange that is permanently attached…
    Category
    Medical Device
    Distribution
    Distributed nationwide