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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1776–1800 of 5038

  • SevereFDA (Devices)·Z-0076-2023·2022-10-26

    Medical gas filter recalled due to splitting and detachment risk

    TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.

    Product
    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0073-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment

    TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

    TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0077-2023·2022-10-26

    Teleflex Catheter Mount and Filter May Split or Detach During Use

    Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.

    Product
    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2023·2022-10-26

    Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

    Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.

    Product
    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0001-2023·2022-10-19

    Jiangsu Well Biotech COVID-19 test kits distributed without FDA authorization

    Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.

    Product
    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1783-2022·2022-10-12

    Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings

    Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.

    Product
    Wisp and Wisp Youth Nasal Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1782-2022·2022-10-12

    DreamWisp CPAP mask recalled for missing implant safety warnings

    Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.

    Product
    DreamWisp Nasal Mask with Over the Nose Cushion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2023·2022-10-12

    Ivenix Infusion System LVP Software Display May Freeze Unresponsive

    Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.

    Product
    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1784-2022·2022-10-12

    Therapy Mask 3100 NC/SP lacks warnings for implantable medical devices

    Philips Respironics is recalling the Therapy Mask 3100 NC/SP because the product lacks warnings about magnetic components that may affect patients with implantable devices or metallic splinters in the eyes.

    Product
    Therapy Mask 3100 NC/SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1781-2022·2022-10-12

    Philips Respironics DreamWear Full Face Mask Lacks Magnetic Hazard Warning

    Philips Respironics is recalling DreamWear Full Face CPAP masks due to missing warnings about magnetic components that may pose risks to patients with implantable devices or metallic eye splinters.

    Product
    Philips Respironics DreamWear Full Face Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2022·2022-10-12

    CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings

    Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.

    Product
    Philips Respironics Amara View Minimal Contact Full-Face Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1763-2022·2022-10-05

    TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide

    FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.

    Product
    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1653-2022·2022-09-21

    Baxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports

    Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.

    Product
    Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1656-2022·2022-09-14

    Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk

    Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.

    Product
    Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1657-2022·2022-09-14

    Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing

    Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.

    Product
    Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1655-2022·2022-09-14

    Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing

    Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.

    Product
    Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1659-2022·2022-09-14

    Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect

    Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.

    Product
    Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1658-2022·2022-09-14

    Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing

    Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.

    Product
    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1654-2022·2022-09-14

    Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

    Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

    Product
    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1521-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2022·2022-09-07

    Medtronic endotracheal tubes recalled for reported airway obstruction risk

    Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.

    Product
    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide