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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23651–23675 of 27699

  • HighFDA (Devices)·Z-1316-2015·2015-04-01

    Brainlab ExacTrac 6.x Patient Positioning Systems Recalled for Positioning Errors

    Brainlab is recalling ExacTrac 6.x systems because they may incorrectly position patients during radiosurgery or radiotherapy when using specific CBCT software.

    Product
    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1302-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal sensor failures and position mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2015·2015-04-01

    Ossur Recalls Rheo Knee Bionic Prosthetic Due to Assembly Defects

    Ossur is recalling two Rheo Knee bionic prosthetic units because they were released for distribution without completing the full assembly process.

    Product
    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1310-2015·2015-04-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to an issue with photon dose calculation for Dynamic MLC plans.

    Product
    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2015·2015-04-01

    GE x|argos 160D Cabinet X-Ray System Recalled for Shielding Defect

    GE Inspection Technologies is recalling two x|argos 160D cabinet x-ray systems because a lead shield fell out of position, creating potential radiation gaps.

    Product
    GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1317-2015·2015-04-01

    BD Q-Syte Luer Access Split Septum Recalled for Leakage

    Becton Dickinson is recalling BD Q-Syte Luer Access Split Septum units due to complaints of blood or medication leakage caused by silicone septum tearing.

    Product
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1306-2015·2015-04-01

    Penner Patient Stretcher/Transfer Lift System Recalled for Tipping Hazard

    Penner Mfg Inc is recalling 158 Patient Stretcher/Transfer Lift Systems because improper patient positioning could cause the device to tip, risking injury to patients or operators.

    Product
    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2015·2015-04-01

    Ameda Dual Short Term HygieniKit Milk Collections System Recalled for Lack of Sterilization

    Ameda is recalling its Dual Short Term HygieniKit Milk Collections System because the devices were not sterilized. Consumers should stop using the product and contact the manufacturer.

    Product
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2015·2015-04-01

    Siemens MAGNETOM MRI Systems Recalled for Gradient Output Supervision Defect

    Siemens Medical Solutions is recalling 132 MAGNETOM MRI systems because a defect in gradient output supervision could allow outputs to exceed safety limits, potentially causing peripheral nerve stimulation.

    Product
    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2015·2015-04-01

    Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure

    Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.

    Product
    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1211-2015·2015-04-01

    GE x|tome|x L240 X-ray System Recalled for Lead Shield Defect

    GE Inspection Technologies is recalling two x|tome|x L240 X-ray systems because a lead shield fell out of position, creating potential radiation exposure gaps.

    Product
    GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1282-2015·2015-03-25

    Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors

    Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.

    Product
    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2015·2015-03-25

    Ossur LP Rotate Foot System Recalled for Insecure Assembly

    Ossur H / F is recalling LP Rotate Foot System prosthetic devices because short threads on the shock module may cause it to detach, leading to falls.

    Product
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2015·2015-03-25

    Medtronic FlexCath Select Steerable Sheath Recalled for Valve Debris

    Medtronic is recalling 151 FlexCath Select Steerable Sheaths because clinicians observed debris originating from the hemostasis valve outside of patients' bodies.

    Product
    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2015·2015-03-25

    Siemens ARTISTE MV System Linear Accelerator Recalled for Software Issue

    Siemens is recalling three ARTISTE MV System linear accelerators due to a software issue that may cause a dark current phenomenon during specific cancer treatments.

    Product
    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1298-2015·2015-03-25

    CooperSurgical Infant Heel Gel Warmers Recalled for Burn Risk

    CooperSurgical is recalling Infant Heel Gel Warmers and The Infant Heel Warmer because products without expiration dates have a remote potential for minor burns.

    Product
    CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2015·2015-03-25

    Stryker Recalls Triathlon Distal Capture Assembly Due to Weld Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,030 Triathlon Distal Capture Assemblies because a weld may disassociate, potentially causing the trigger mechanism to become loose or disassociated.

    Product
    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2015·2015-03-25

    GE Healthcare Treadmill T2100 and T2000 Power Cord Recall

    GE Healthcare is recalling T2100 and T2000 treadmills due to a potential safety issue with the power cord assembly.

    Product
    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1238-2015·2015-03-25

    Elekta Precise Treatment Table Recalled for Positioning Error Risk

    Elekta is recalling Precise Treatment Tables because incorrect sensor installation during maintenance can cause undetected positioning errors, potentially leading to clinical mistreatment.

    Product
    Elekta Precise Treatment Table
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2015·2015-03-25

    Synthes Thumb Screws Recalled Due to Incorrect Stainless Steel Material

    Synthes, Inc. is recalling 183 thumb screws for orthopedic aiming arms because incorrect raw material was used, which may lead to stress-corrosion cracking.

    Product
    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2015·2015-03-25

    CooperSurgical Recalls MediChoice Infant Heel Warmers for Burn Risk

    CooperSurgical is recalling MediChoice Infant Heel Warmers because products without expiration dates have a remote potential for minor burns.

    Product
    MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2015·2015-03-25

    Mindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings

    Mindray is recalling 519 Passport V Monitors because the invasive blood pressure function may provide incorrect measurements.

    Product
    Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in…
    Category
    Medical Device
    Distribution
    Distributed nationwide