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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9601–9625 of 13748

  • HighFDA (Devices)·Z-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk

    Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.

    Product
    Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2023·2023-04-19

    Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

    Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

    Product
    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2023·2023-04-19

    Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients

    Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.

    Product
    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2023·2023-04-19

    Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk

    Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.

    Product
    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2023·2023-04-19

    X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge

    Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.

    Product
    ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2023·2023-04-19

    PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction

    Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2023·2023-04-19

    Chromic Gut Absorbable Sutures recalled due to sterilization failure

    Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.

    Product
    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2023·2023-04-19

    Inflatable Penile Prosthesis Pump Risk of Premature Failure

    Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.

    Product
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.

    Product
    Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

    Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.

    Product
    Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2023·2023-04-19

    Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk

    Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.

    Product
    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2023·2023-04-19

    Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect

    Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.

    Product
    Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2023·2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1355-2023·2023-04-19

    Medical X-ray Systems Recalled for Electrical Fire Hazard

    Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.

    Product
    CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2023·2023-04-19

    Digital VIPR Oxygen Delivery Systems Recalled for Gauge Malfunction

    Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.

    Product
    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2023·2023-04-19

    Step Bladeless Trocars recalled for sterilization failure

    Covidien's Step Bladeless Trocars (Model S101010, Lot P2G0069) are being recalled due to a sterilization process failure that may have resulted in unsterile instruments. Use of affected units may lead to infection or vision loss in eye procedures.

    Product
    Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

    Product
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2023·2023-04-19

    X-ray imaging system ceiling suspension may descend without adequate maintenance

    Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.

    Product
    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling 15 units of the Titan Touch Infr Zero Ang inflatable penile prosthesis (Lot Numbers 8849582, 8849603, 8904185) worldwide due to decreased wall thickness that may cause premature pump failure.

    Product
    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.

    Product
    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2023·2023-04-19

    Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

    Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.

    Product
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

    Product
    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide