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 deaths or serious injuries are reported, 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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4051–4075 of 39948

  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2025·2025-04-30

    Novasight Hybrid Catheter Recalled for Potential Sheath Detachment

    Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.

    Product
    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1643-2025·2025-04-30

    Amplatzer TorqVue LP Delivery System Recall for Shaft Breach

    Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2025·2025-04-30

    Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk

    Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.

    Product
    Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2025·2025-04-30

    InPen Smart Insulin Pen Recall Due to Incorrect Assembly

    Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.

    Product
    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1652-2025·2025-04-30

    CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect

    Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2025·2025-04-30

    Abbott CELL-DYN Ruby hematology analyzer affected by expired reagent date masking

    Abbott is recalling the CELL-DYN Ruby hematology analyzer because expired reagents may have their expiration dates automatically changed to current or future dates without user notification, potentially leading to use of expired reagents.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2025·2025-04-30

    Medtronic NIM Vital Nerve Monitoring System Software Version Recall

    Medtronic is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased stimulus artifact that may require troubleshooting and could lead to procedure delay, extubation, and medical intervention.

    Product
    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer medical device recall

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer system expiration date validation

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2025·2025-04-30

    BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect

    CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.

    Product
    BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2025·2025-04-30

    Zenition 70 Radiological System Wireless Foot Switch Recall

    Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.

    Product
    Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1657-2025·2025-04-30

    Globus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly

    Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.

    Product
    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2025·2025-04-30

    Skytron Freedom Monitor Mount Hardware Recall for Inadequate Thread Engagement

    The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.

    Product
    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2025·2025-04-30

    Rover Mobile X-ray System internal fastening mechanism failure potential

    Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring med
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1651-2025·2025-04-30

    Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking

    A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.

    Product
    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1670-2025·2025-04-30

    Rover Mobile X-ray System internal fastening mechanism failure risk

    Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagno
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1580-2025·2025-04-30

    Zenition 50 Medical Imaging Devices Wireless Foot Switch Recall

    Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.

    Product
    Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1653-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer expiration date software defect

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2025·2025-04-30

    Veradius Unity wireless foot switch pedal may emit unintended radiation

    Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.

    Product
    Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1660-2025·2025-04-30

    Philips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard

    Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.

    Product
    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2025·2025-04-30

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break

    Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2025·2025-04-30

    Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Information

    Zimmer, Inc. is recalling a ceramic hip prosthesis head because its labeling does not adequately describe compatibility with cobalt-chrome or stainless-steel femoral stems.

    Product
    Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1648-2025·2025-04-30

    Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Compatibility Labeling

    Zimmer, Inc. is recalling a ceramic femoral head for hip prosthesis (Model 802802202, 22.2 mm) because product labeling does not adequately describe compatibility with certain metal femoral stems.

    Product
    Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1649-2025·2025-04-30

    Zimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information

    Zimmer, Inc. is recalling a ceramic hip prosthesis head because the product labeling does not adequately describe compatibility with certain femoral stems used in hip replacement surgery.

    Product
    Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide