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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16401–16425 of 39988

  • HighFDA (Devices)·Z-2817-2020·2020-08-26

    Golden Technologies Lift Chair Recalled for Suspected Poor Weld

    Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.

    Product
    Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2806-2020·2020-08-26

    Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets

    Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.

    Product
    ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2814-2020·2020-08-26

    Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton

    Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.

    Product
    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2825-2020·2020-08-26

    CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2826-2020·2020-08-26

    CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2830-2020·2020-08-26

    Pharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads

    Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads because the device was incorrectly registered as a Class I device and requires a 510(k) submission.

    Product
    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2020·2020-08-26

    Chembio DPP Micro Reader Recalled for Performance Issues

    Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2020·2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2809-2020·2020-08-26

    Chembio DPP Micro Reader II Recalled for Performance Issues

    Chembio Diagnostics is recalling 97 DPP Micro Reader II kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2829-2020·2020-08-26

    Cytocell NUP98 Distal Probe Green Recalled for False Positive Risk

    Cytocell Ltd. is recalling NUP98 Distal Probe Green units due to a low risk of false positive results in laboratory testing.

    Product
    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2020·2020-08-26

    CareFusion Alaris PCA Module 8120 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2823-2020·2020-08-26

    CareFusion Alaris Syringe Module LED Display Dimness Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2827-2020·2020-08-26

    Smith & Nephew Recalls Polarstem Collar Reamer Guides Due to Design Issue

    Smith & Nephew is recalling 528 units of the Polarstem Collar Reamer Guide due to a product design issue. The devices were distributed worldwide and in the US.

    Product
    POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2812-2020·2020-08-26

    Philips Module Charger Recall for MRI Patient Monitoring System

    Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.

    Product
    Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2822-2020·2020-08-26

    CareFusion Alaris Pump Module 8100 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2810-2020·2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2811-2020·2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2795-2020·2020-08-19

    Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk

    Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.

    Product
    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2020·2020-08-19

    Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

    Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

    Product
    Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.

    Product
    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2020·2020-08-19

    Anjon Holdings Recalls Spinal Bone Fixation Fasteners Due to Galling

    Anjon Holdings is recalling 249 Anjon Bremer Molded Crown bone fixation fasteners because of a high rate of galling in a threaded component.

    Product
    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2020·2020-08-19

    Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide