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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

23476–23500 of 27663

  • HighFDA (Devices)·Z-1576-2015·2015-05-13

    B. Braun Medical Recalls Pain Control Trays Due to Sterile Barrier Risk

    B. Braun Medical is recalling specific pain control trays because a potential hole in the outer tray may compromise the sterile barrier, posing a risk of contamination.

    Product
    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • HighFDA (Devices)·Z-1406-2015·2015-05-06

    GE Healthcare Recalls Optima XR200 amx Mobile X-Ray Units

    GE Healthcare is recalling six Optima XR200 amx mobile X-ray units in the US due to potential mAs accuracy issues that may affect exposure times.

    Product
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1556-2015·2015-05-06

    CareFusion LightWand Stylet Recalled for Sterile Packaging Breach Risk

    Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.

    Product
    CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2015·2015-05-06

    Lumenis Light Sheer Desire Diode Laser System Recalled for Software Error

    Lumenis is recalling 117 Light Sheer Desire Diode Laser Systems because software parameters exceed manual settings, potentially causing burns.

    Product
    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2015·2015-05-06

    GE Healthcare Recalls Brivo XR285amx Mobile X-Ray Units

    GE Healthcare is recalling six Brivo XR285amx mobile X-ray units in the US due to potential inaccuracies in mAs accuracy checks.

    Product
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1546-2015·2015-05-06

    Pega Medical Recalls Female Driver Instruments for Orthopedic Procedures

    Pega Medical Inc. is recalling 9 Female Driver instruments used in orthopedic procedures because the hexagonal tip is 0.06 mm under specifications, which may lead to breakage.

    Product
    Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1553-2015·2015-05-06

    Synthes Small Battery Drive Oscillating Saw Attachment Recall

    The Anspach Effort, Inc. is recalling Synthes Small Battery Drive Oscillating Saw Attachments because they may disengage during surgery, posing a risk of injury.

    Product
    Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2015·2015-05-06

    Steris Caviwave Pro Ultrasonic Cleaning System Recalled for Power Failure Risk

    Steris is recalling 491 Caviwave Pro Ultrasonic Cleaning Systems because a power interruption may stop the pump and generator without alerting the user.

    Product
    Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2015·2015-05-06

    Nihon Kohden Remote Network Station Recall for Alarm Failure

    Nihon Kohden America is recalling 208 Remote Network Station units because they may fail to sound alarms for critical patient conditions.

    Product
    Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1557-2015·2015-05-06

    Vital Signs LightWand Stylet Recalled for Sterile Packaging Breach

    Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.

    Product
    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1521-2015·2015-05-06

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems with software version 2.8 or below due to a potential anomaly that may cause the device to process samples with the wrong cartridge, leading to erroneous patient results.

    Product
    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in…
    Category
    Medical Device
    Distribution
    1 state