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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13526–13550 of 13802

  • HighFDA (Devices)·Z-1976-2021·2021-07-07

    Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly

    Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.

    Product
    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2021·2021-07-07

    Pressure monitoring set recalled for potential pressure tubing detachment

    Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.

    Product
    Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1968-2021·2021-07-07

    SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations

    Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes due to possible deviations in the ethylene oxide sterilization process. The recalled units may not be adequately sterilized, posing a potential infection risk to users.

    Product
    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1969-2021·2021-07-07

    Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1978-2021·2021-07-07

    NeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results

    NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.

    Product
    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1993-2021·2021-07-07

    Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling

    One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.

    Product
    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2021·2021-07-07

    Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk

    Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2021·2021-07-07

    Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1960-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall

    Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.

    Product
    Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
    Category
    Medical Device
    Distribution
    33 states
  • SevereFDA (Devices)·Z-1863-2021·2021-06-30

    Nitric Oxide Delivery System Dosing Deficiency During Console Transitions

    GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.

    Product
    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2021·2021-06-30

    Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.

    Product
    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1920-2021·2021-06-30

    Medical Probe Cover Recalled Due to Missing FDA Premarket Clearance

    Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.

    Product
    Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1916-2021·2021-06-30

    Transducer Cover Lacks FDA 510(k) Clearance for Surgical Use

    Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1918-2021·2021-06-30

    Hays Ultrasound Kit Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Hays Ultrasound kit Item ID: H1000SE
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1926-2021·2021-06-30

    reSET-O Mobile App Recall: Software Defect Allows Incorrect Reward Access

    Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.

    Product
    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1910-2021·2021-06-30

    Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.

    Product
    6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1950-2021·2021-06-30

    Econocare Plus Waffle Overlay Recalled for Bodily Fluid Contamination

    EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.

    Product
    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2021·2021-06-30

    AeroChamber PLS Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.

    Product
    AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2021·2021-06-30

    SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000

    Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.

    Product
    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2021·2021-06-30

    Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors

    Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2021·2021-06-30

    FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure

    Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.

    Product
    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2021·2021-06-30

    SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions

    This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.

    Product
    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1924-2021·2021-06-30

    Ultrasonic Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1902-2021·2021-06-30

    Ventec VOCSN Ventilators May Shut Down Due to Component Failure

    Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.

    Product
    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-00
    Category
    Medical Device
    Distribution
    Distributed nationwide