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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9776–9800 of 27441

  • SevereFDA (Devices)·Z-1314-2022·2022-07-13

    Palindrome Precision SI Chronic Catheters Recalled for Potential Hub Leaking

    Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.

    Product
    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2022·2022-07-13

    Cardiac Troponin Diagnostic Test Recalled for Positive Bias in Plasma Samples

    Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.

    Product
    Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2022·2022-07-13

    Medical Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1311-2022·2022-07-13

    NaturaLyte 2301 dialysate recalled for storage exposure and leaks

    Fresenius Medical Care recalled NaturaLyte 2301 dialysate in Texas and Louisiana after exposure to below-recommended storage temperatures. The exposure may cause packaging leaks, potentially leading to biological contamination and bloodstream infection risk.

    Product
    NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2022·2022-07-13

    Ossur Variflex Suba Junior prosthetic foot may crack under impact

    Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.

    Product
    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2022·2022-07-13

    Rayner RayOne Intraocular Lens Systems Mislabeled with Incorrect Lens Strength

    Rayner is recalling RayOne intraocular lens injection systems because the outer package is mislabeled and contains a different lens strength than indicated. Approximately 162 devices were distributed in 13 US states.

    Product
    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2022·2022-07-13

    ABL800 Flex Analyzer Recalled for Potential Measurement Bias

    Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.

    Product
    ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2022·2022-07-13

    EEA Autosuture Circular Staplers Recalled for Staple Guide Detachment Risk

    Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.

    Product
    EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2022·2022-07-13

    Abbott TactiCath Ablation Catheter System Error Display Malfunction

    Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.

    Product
    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2022·2022-07-13

    Imaging system software displays mirrored CT images during data loading

    Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.

    Product
    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2022·2022-07-13

    VERIGENE Enteric Pathogens Test may yield false negative results

    Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.

    Product
    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2022·2022-07-13

    Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction

    Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400T Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2022·2022-07-13

    Omnera 400A Digital Radiographic System: Electrical Short Circuit Hazard

    Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.

    Product
    Omnera 400A Digital Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2022·2022-07-13

    Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk

    Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.

    Product
    Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2022·2022-07-13

    CELLSEARCH Circulating Tumor Cell Kit Recalled for False Positive Risk

    Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.

    Product
    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1340-2022·2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2022·2022-07-13

    Laboratory Control Material Recalled for Insufficient Glycine Concentration

    Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.

    Product
    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1333-2022·2022-07-13

    GE Centricity Medical Imaging Software Displays Inaccurate Measurements

    GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.

    Product
    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1343-2022·2022-07-13

    Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use

    Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.

    Product
    Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2022·2022-07-13

    Verigene CDF Nucleic Acid Test recalled for potential false negative results

    Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.

    Product
    Verigene CDF Nucleic Acid Test, Part No. 30-002-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2022·2022-07-06

    Alphenix 4D CT system may stop operating due to system error

    The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.

    Product
    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1298-2022·2022-07-06

    TEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager

    Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.

    Product
    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2022·2022-07-06

    Orthopedic Plates Recalled Due to Incorrect Etching and Mislabeling

    One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.

    Product
    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2022·2022-07-06

    Backup batteries in Avance CS2 anesthesia machines fail prematurely

    GE Healthcare is recalling backup batteries in Avance CS2 and CS2 Pro anesthesia machines manufactured after April 1, 2019. Batteries may fail earlier than expected, affecting approximately 6,600 devices worldwide.

    Product
    Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2022·2022-07-06

    GCX Channel Mounting Accessory Screws May Loosen or Pull Out

    Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.

    Product
    Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
    Category
    Medical Device
    Distribution
    Distributed nationwide