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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13051–13075 of 13802

  • SevereFDA (Devices)·Z-2391-2021·2021-09-15

    FDA Recalls Ultrasound Gel for Risk of Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.

    Product
    LiquaSonic Ultrasound Gel 250mL, Model No. 001205
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2403-2021·2021-09-15

    EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

    Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

    Product
    EV3 Pipeline Flex Embolization Device with Flex Shield Technology
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-2377-2021·2021-09-15

    NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

    Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

    Product
    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2376-2021·2021-09-15

    NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

    Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

    Product
    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2021·2021-09-15

    MRI diagnostic device tabletop may not move completely in manual mode

    Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2021·2021-09-15

    MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode

    Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.

    Product
    Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2021·2021-09-15

    Ingenia Ambition S-a MRI System tabletop may not move in manual mode

    The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2021·2021-09-15

    MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment

    Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.

    Product
    SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2021·2021-09-15

    Guide Catheters Recalled for Potential Sterilization Defect

    Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.

    Product
    MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selecte
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2426-2021·2021-09-15

    Medical diagnostic kit requires more frequent calibration than Instructions stated

    The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2021·2021-09-15

    Philips MRI System Tabletop May Not Fully Move in Manual Mode

    Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.

    Product
    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2021·2021-09-15

    Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator

    Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.

    Product
    Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2021·2021-09-15

    MRI Tabletop May Not Move Properly in Manual Mode

    The patient tabletop on affected Philips Ingenia Elition MRI systems may not move completely in or out during manual operation, potentially delaying patient evacuation from the device.

    Product
    Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2021·2021-09-15

    COPAN FLOQSwabs Recalled Over Sterilization Integrity Failure

    Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.

    Product
    COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2021·2021-09-15

    Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

    Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

    Product
    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2422-2021·2021-09-15

    Philips Ingenia Ambition X MRI System Tabletop May Fail to Retract

    Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 units distributed worldwide.

    Product
    Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2021·2021-09-15

    Philips HEARTSTART Infant/Child Defibrillator Pads Recalled for Incorrect Labeling

    Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.

    Product
    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2021·2021-09-15

    MRI device tabletop may fail to move completely in manual mode

    Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.

    Product
    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 7813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2442-2021·2021-09-15

    MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect

    Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.

    Product
    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blo
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2412-2021·2021-09-15

    Philips Ingenia 1.5T MRI tabletop malfunction may delay patient evacuation

    Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2021·2021-09-15

    Proteus 235 Proton Therapy System May Display Misleading Popup Message

    Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.

    Product
    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2420-2021·2021-09-15

    Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure

    Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.

    Product
    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2021·2021-09-15

    Arc Endocuff Vision endoscopic device recalled for packaging seal defects

    Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.

    Product
    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be att
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2021·2021-09-15

    Medical Device Test Kit Requires More Frequent Calibration Than Labeled

    Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2021·2021-09-15

    MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems

    Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
    Category
    Medical Device
    Distribution
    Distributed nationwide