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 deaths or serious injuries are reported, 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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3951–3975 of 5038

  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • CriticalFDA (Devices)·Z-1529-2016·2016-04-27

    Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard

    Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.

    Product
    MEVION S250 for Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1551-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1530-2016·2016-04-27

    Acorn 180 Curved Stairlift Recalled Due to Broken Rivets

    Acorn Stairlifts Inc is recalling 1,290 Acorn 180 Curved Stairlifts in the US because aluminum rivets may break under prolonged use.

    Product
    Acorn 180 Curved Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2016·2016-04-20

    Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues

    Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1393-2016·2016-04-20

    RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk

    RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.

    Product
    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1422-2016·2016-04-20

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1481-2016·2016-04-20

    Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1275-2016·2016-04-13

    FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

    Product
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2016·2016-04-13

    ScottCare TeleSentry Battery Recall Due to Explosion Risk During Recharging

    ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.

    Product
    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient sympto
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-1327-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1323-2016·2016-04-13

    MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking

    MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.

    Product
    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2016·2016-04-06

    Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1309-2016·2016-04-06

    ViewRay MRIdian Radiation Therapy System Software Recall

    ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.

    Product
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1220-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1242-2016·2016-03-30

    Siemens IMMULITE 1000 Estradiol Test Recalled for Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated results.

    Product
    IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1219-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1181-2016·2016-03-23

    Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues

    Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.

    Product
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1063-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2016·2016-03-16

    Stryker Position Pro Mattress Recalled for Power Cord Fire Risk

    Stryker is recalling Position Pro Mattresses because the power cord may melt, posing risks of electric shock and fire.

    Product
    Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated contro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2016·2016-03-09

    NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk

    NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.

    Product
    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide