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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

33376–33400 of 40449

  • ModerateFDA (Devices)·Z-1344-2015·2015-04-08

    Microtek Medical Recalls Vacuum Tubing Due to Unlabeled Latex Packaging

    Microtek Medical Inc is recalling non-sterile vacuum tubing because the packaging contains latex but lacks the required warning label.

    Product
    VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1365-2015·2015-04-08

    Medtronic Recalls Trellis 6 and 8 Peripheral Infusion Systems for Sterility Breach

    Medtronic is voluntarily recalling Trellis 6 and 8 Peripheral Infusion Systems due to potential sterility breaches in the outer packaging.

    Product
    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2015·2015-04-08

    Siemens Syngo.plaza PACS Recalled for Incomplete Archived Studies

    Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.

    Product
    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1307-2015·2015-04-01

    Philips Recalls Lithium Polymer Fiber Optic Module Batteries Due to Ignition Risk

    Philips Medical Systems is recalling 79 lithium polymer fiber optic module batteries used in Intera MR Systems because a battery ignited during recharging.

    Product
    Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring…
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1290-2015·2015-04-01

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System because the outer layer may flake off, potentially causing a flow-limiting embolism.

    Product
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1324-2015·2015-04-01

    Titan Spine Recalls TCS Straight Hexalobe Drivers Due to Tip Shearing

    Titan Spine, LLC is recalling 26 Endo TCS Driver Straight Hexalobe #6 units because the tips sheared off during use in patients with dense bones.

    Product
    Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1326-2015·2015-04-01

    Ameda One-Hand Manual Breast Pump Recalled for Lack of Sterilization

    Ameda, Inc. is recalling 1,763 units of the One-Hand Manual Breast Pump (SKU 17161) because the devices were not sterilized.

    Product
    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2015·2015-04-01

    GE Healthcare Recalls MRI Systems Due to Software Maintenance Issues

    GE Healthcare is recalling 9,369 MRI systems worldwide because software versions were not maintained properly at some sites.

    Product
    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

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

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. 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-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
  • ModerateFDA (Devices)·Z-1325-2015·2015-04-01

    Zimmer NexGen Trabecular Metal Femoral Augment Block Mislabeled Recall

    Zimmer Trabecular Metal Technology is recalling one unit of a NexGen femoral augment block that was mislabeled as 5 mm instead of 20 mm.

    Product
    NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1311-2015·2015-04-01

    CareFusion Recalls Alaris PC Infusion Pumps Due to Keypad Error Code

    CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.

    Product
    Alaris PC units, Model No. 8015. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2015·2015-04-01

    Synthes Electric Pen Drive Hand Switch Labeling Error Recall

    Synthes, Inc. is recalling 249 Electric Pen Drive systems because the Hand Switch labels for 'on' and 'lock' were interchanged.

    Product
    Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide