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)

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25651–25675 of 40397

  • HighFDA (Devices)·Z-0060-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plates

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0021-2018·2017-11-01

    OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation

    OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.

    Product
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0043-2018·2017-11-01

    MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect

    MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.

    Product
    MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2018·2017-11-01

    FDA Requests Removal of Ablatherm Ultrasound System Software Settings

    FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.

    Product
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0044-2018·2017-11-01

    Bard Max-Core Biopsy Instruments Recalled for Malfunction

    Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or obtain samples.

    Product
    BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0050-2018·2017-11-01

    Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size

    Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.

    Product
    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2018·2017-11-01

    GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk

    W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.

    Product
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0046-2018·2017-11-01

    Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error

    Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.

    Product
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0045-2018·2017-11-01

    Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results

    Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.

    Product
    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2018·2017-11-01

    Becton Dickinson Recalls ChloraPrep Applicators Due to Labeling Error

    Becton Dickinson is recalling 628,000 ChloraPrep OneStep applicators because the immediate package is incorrectly labeled as Clear instead of Hi Lite Orange.

    Product
    ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0042-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2018·2017-11-01

    Siemens Medical Solutions Recalls Torque Wrenches for Symbia CT Devices

    Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.

    Product
    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0023-2018·2017-10-25

    St. Jude Medical Recalls Infinity 5 and 7 Implantable Pulse Generators

    St. Jude Medical is recalling 3,119 Infinity 5 and 7 Implantable Pulse Generators because battery longevity estimations may be inaccurate.

    Product
    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2018·2017-10-25

    St Jude Medical Recalls Assurity MRI Pacemakers for Firmware Update

    St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0040-2018·2017-10-25

    Genesys Binary Screwdriver Recalled Due to Threaded Shaft Breakage

    Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.

    Product
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0032-2018·2017-10-25

    St. Jude Medical Recalls Merlin PCS 3650 Programmer for Firmware Update

    St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.

    Product
    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0038-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Firmware Security Update

    St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0037-2018·2017-10-25

    St Jude Medical Recalls PM 1260 Assurity+ Pacemakers for Firmware Update

    St Jude Medical is recalling 6,051 PM 1260 Assurity+ pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0034-2018·2017-10-25

    St Jude Medical Recalls Nuance Pacemakers for Firmware Update

    St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' radio frequency communications.

    Product
    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0033-2018·2017-10-25

    St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security

    St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.

    Product
    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0022-2018·2017-10-25

    St. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators

    St. Jude Medical is recalling 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.

    Product
    Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
    Category
    Medical Device
    Distribution
    Distributed nationwide