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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26126–26150 of 40357

  • CriticalFDA (Devices)·Z-2736-2017·2017-08-02

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100i Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2737-2017·2017-08-02

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2738-2017·2017-08-02

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.

    Product
    CS 300 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2017·2017-08-02

    Invuity PhotonBlade Recalled for Potential Unintended Energy Discharge

    Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.

    Product
    INVUITY(R) PhotonBlade(TM), REF PB1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2017·2017-08-02

    Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2017·2017-08-02

    Fisher Diagnostics Recalls FDP Assay Kits Due to False Negative Risk

    Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.

    Product
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2017·2017-08-02

    Biomerieux Recalls VITEK 2 Gram Negative Test Kits Due to Errors

    Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.

    Product
    VITEK 2 Gram Negative test kits containing colistin (cs01n)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2763-2017·2017-08-02

    Fisher Diagnostics Recalls FDP Latex Reagent Due to Reduced Sensitivity

    Fisher Diagnostics is recalling specific lots of Pacific Hemostasis FDP Latex Reagent because reduced sensitivity may cause false negative test results.

    Product
    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2017·2017-08-02

    Medtronic Recalls DLP Pressure Monitoring Extension Line Adapters

    Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.

    Product
    DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2017·2017-08-02

    Medtronic DLP Antegrade/Retrograde Adapter Recalled for Packaging Pinholes

    Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2768-2017·2017-08-02

    Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.

    Product
    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2017·2017-08-02

    Atrium iCAST and Advanta V12 Stents Recalled for Incorrect Hub Labeling

    Atrium Medical Corporation is recalling specific iCAST and Advanta V12 covered stents because the catheter hub was printed with incorrect dimensional information.

    Product
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2766-2017·2017-08-02

    Medtronic Recalls DLP Cardioplegia Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.

    Product
    DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2757-2017·2017-08-02

    Cardinal Health Recalls Mislabeled Sterile Surgical Drapes

    Cardinal Health is recalling specific lots of sterile surgical drapes because the outer labels do not match the packaged product inside.

    Product
    Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2758-2017·2017-08-02

    Cardinal Health Recalls Tiburon Arthroscopy Drapes Due to Labeling Mismatch

    Cardinal Health is recalling specific lots of Tiburon Arthroscopy Drapes because the outer labels do not match the packaged product.

    Product
    Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2755-2017·2017-08-02

    Medtronic Visualase Cooled Laser Applicator System Recalled for Seal Defect

    Medtronic is recalling 214 units of the Visualase Cooled Laser Applicator System because the cap may fail to seal, causing saline leaks.

    Product
    Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2759-2017·2017-08-02

    Smiths Medical CADD IV Administration Set Recalled for Missing Expiration Date

    Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.

    Product
    Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2756-2017·2017-08-02

    PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch

    PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers did not match the devices inside.

    Product
    PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
    Category
    Medical Device
    Distribution
    1 state