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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33151–33175 of 40449

  • 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
  • HighFDA (Devices)·Z-1542-2015·2015-05-06

    Spacelabs Ultraview SL Command Modules Recalled for Monitoring Suspension

    Spacelabs is recalling Ultraview SL Command Modules upgraded with the Masimo SpO2 Option because monitoring suspends for approximately 10 seconds during resets.

    Product
    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2015·2015-05-06

    AmTryke Model 1424 Hand Cycle Recalled for Cracked Frames

    Amtryke LLC is recalling 53 Model 1424 Community Cruiser Hand Cycles due to complaints of cracked frames. The recall covers units distributed nationwide to 18 states.

    Product
    AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2015·2015-05-06

    Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2015·2015-05-06

    Bard Access Systems Recalls PowerLoc MAX Safety Winged Infusion Set

    Bard Access Systems is recalling 700 units of the PowerLoc MAX Safety Winged Infusion Set due to a potential incorrect Maximum Flow rate label on the packaging.

    Product
    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1527-2015·2015-05-06

    MedComp Recalls 9F Plastic Dual Port Vascular Access Devices

    Medical Components, Inc. is recalling 325 units of 9F Plastic Dual Port vascular access devices because they were not covered under FDA clearance.

    Product
    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2015·2015-05-06

    Cyberonics Recalls VNS Therapy DemiPulse Generators Due to Battery Defect

    Cyberonics is recalling 13 VNS Therapy DemiPulse Generators because they were left in an ON state during manufacture, causing lower battery longevity than specified.

    Product
    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1407-2015·2015-05-06

    GE Healthcare Recalls Six Optima XR220 amx Mobile X-Ray Units

    GE Healthcare is recalling six Optima XR220 amx mobile X-ray units in the US due to potential mAs accuracy inaccuracies.

    Product
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1528-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1551-2015·2015-05-06

    Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2015·2015-05-06

    Steris Recalls AMSCO Steam Sterilizers Due to Software Defect

    Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-1523-2015·2015-05-06

    Zimmer Anatomical Shoulder Handle Recalled Due to Attachment and Removal Difficulties

    Zimmer GmbH is recalling 30 units of Anatomical Shoulder Handles for Rasps due to high resistance during attachment and seizing during removal, which may delay surgery.

    Product
    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1547-2015·2015-05-06

    Alphatec Spine Recalls Mislabeled 14mm Trestle Luxe Cervical Screws

    Alphatec Spine is recalling 14mm Trestle Luxe screws that were incorrectly labeled and laser-marked as 14mm but are actually 16mm.

    Product
    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1539-2015·2015-05-06

    Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna because the product was distributed without the required FDA 510(k) approval.

    Product
    FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Medical Device
    Distribution
    Distributed nationwide