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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33126–33150 of 40449

  • HighFDA (Devices)·Z-1568-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2015·2015-05-13

    Philips EPIQ 7 Ultrasound System Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 7 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2015·2015-05-13

    Philips EPIQ 5 Ultrasound Systems Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.

    Product
    119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain devices because of a potential sterility breach in the packaging.

    Product
    1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2015·2015-05-13

    Siemens Axiom Aristos FX Radiography System Cable Cart Recall

    Siemens is recalling 43 Axiom Aristos FX radiography systems because a cable cart defect could cause the cable holder to drop and hit patients or operators.

    Product
    AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2015·2015-05-13

    Brainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors

    Brainlab AG is recalling ExacTrac 6.x software due to potential patient positioning errors when using CBCT at non-zero couch angles.

    Product
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage.

    Product
    113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation

    ICU Medical is recalling 1,500 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

    ICU Medical is recalling 13,800 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.

    Product
    3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling 1/8 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker Instruments is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2015·2015-05-13

    Zimmer NexGen Augment Recalled for Missing Locking Screw

    Zimmer, Inc. is recalling 20 units of NexGen Augment knee implants because they were packaged without the required locking screw, which may delay surgery.

    Product
    NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1566-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker is voluntarily recalling 3/16 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures

    Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.

    Product
    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1584-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Loss

    Siemens Medical Solutions USA is recalling 476 ACUSON SC2000 ultrasound systems because post-exercise images may be lost during Stress Echo procedures.

    Product
    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1585-2015·2015-05-13

    Fujifilm Aspire HD Mammography System Recalled for User Manual Error

    Fujifilm is recalling one Aspire HD mammography system in Hawaii because the user manual lacks descriptions for handling certain recoverable errors.

    Product
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1587-2015·2015-05-13

    Stryker Universal Battery Charger Recalled for Software Data Transmission Issue

    Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.

    Product
    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2015·2015-05-06

    Baxter Patient Control Modules Recalled for Potential Malfunction

    Baxter Healthcare is recalling 7,596 Patient Control Modules due to a potential malfunction that could cause medication to flow when it should not.

    Product
    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1548-2015·2015-05-06

    Dako Omnis Software Module Recalled for Test Request Errors

    Dako North America is recalling the Test Request Distributor software module for the Dako Omnis System because it may execute the wrong test after a user updates a request.

    Product
    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test…
    Category
    Medical Device
    Distribution
    Distributed nationwide