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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

31376–31400 of 40325

  • HighFDA (Devices)·Z-0413-2016·2015-12-23

    GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

    GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

    Product
    GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2016·2015-12-23

    bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

    bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2016·2015-12-23

    Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction

    Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.

    Product
    MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0447-2016·2015-12-23

    Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure

    Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.

    Product
    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2016·2015-12-23

    Philips Ingenuity Core CT Scanner Software Recall

    Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned during specific protocols.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2016·2015-12-23

    Myco Medical Supplies Recalls Unolok Blunt Fill Needles Due to Particulates

    Myco Medical Supplies Inc is recalling Unolok Blunt Fill Needles because complaints were received regarding rubber coring from injection vial closures.

    Product
    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2016·2015-12-23

    bioMerieux MYLA Software Recall for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records.

    Product
    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2016·2015-12-23

    Bestmed Digital Temple Thermometers Recalled for Inaccurate Temperature Readings

    Bestmed is recalling 305,548 digital temple thermometers sold under multiple retail brands because they display inaccurate, frequently lower temperatures than actual body temperature.

    Product
    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2016·2015-12-23

    Philips Ingenuity CT Scanner Software Error Recalled by FDA

    The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2016·2015-12-23

    bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2016·2015-12-23

    Philips CT Scanner Software Error May Alter Scan Length

    Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.

    Product
    Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2016·2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0435-2016·2015-12-23

    Summit Medical Recalls AbsorbENT Nasal Packs Due to Missing Split

    Summit Medical is recalling specific lots of AbsorbENT nasal packs because the product lacks a required split in the packing.

    Product
    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0418-2016·2015-12-23

    Fujifilm Medical Systems Recalls Duodenoscopes for Reprocessing Design Changes

    Fujifilm Medical Systems is recalling specific duodenoscope models as a precautionary measure because the devices have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.

    Product
    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0405-2016·2015-12-23

    Philips Brilliance 64 CT System Software Error Recall

    Philips is recalling seven Brilliance 64 CT systems because software may set the scan length differently than planned.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and 600 Hematology Analyzer Software

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the software allows the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and DxH 600 Software Versions

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the systems allow multiple orders to share the same specimen ID with different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0446-2016·2015-12-23

    Edwards Lifesciences Recalls IV Administration Sets for Regulatory Submission

    Edwards Lifesciences is recalling 147,350 units of IV Administration Sets because an additional FDA submission is required to support commercialization.

    Product
    Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0374-2016·2015-12-16

    Philips IntelliVue Information Center iX Software Recall for Alarm Failure

    Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.

    Product
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2016·2015-12-16

    Philips Brilliance 64 CT System Recalled for Software Defects

    Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.

    Product
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2016·2015-12-16

    Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems

    Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.

    Product
    Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
    Category
    Medical Device
    Distribution
    4 states