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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13576–13600 of 13837

  • HighFDA (Devices)·Z-1912-2021·2021-06-30

    Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.

    Product
    6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1901-2021·2021-06-30

    Sterile Colorectal Anoscopes and Proctoscopes Recalled Due to Falsified Sterilization Records

    Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.

    Product
    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1927-2021·2021-06-30

    Cardiac assessment system may display test reports in wrong patient records

    GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

    Product
    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
    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-1908-2021·2021-06-30

    Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.

    Product
    Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
    Category
    Medical Device
    Distribution
    5 states
  • 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-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-1941-2021·2021-06-30

    OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.

    Product
    OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2021·2021-06-30

    Ultrasonic Probe Covers Lack FDA Clearance for Body Use

    Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1903-2021·2021-06-30

    Blood Culture Identification Panel Recalled Due to Manufacturing Defect

    BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.

    Product
    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2021·2021-06-30

    Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1938-2021·2021-06-30

    OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings

    Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.

    Product
    ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2021·2021-06-30

    Ultrasonic Probe Cover Recalled Due to Lack of FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 12,650 ultrasonic probe covers (Item A-AU-0980N) that were marketed for use in body cavities without FDA 510(k) clearance.

    Product
    Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1929-2021·2021-06-30

    Freestyle Lancets 28G Recalled Due to Temperature Damage During Shipping

    Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.

    Product
    FREESTYLE LANCETS 28G 100CT Item Number:2975670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2021·2021-06-30

    Medical Device Recall: reSET App Grants Rewards Despite Positive Drug Screens

    The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.

    Product
    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
    Category
    Medical Device
    Distribution
    16 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-1944-2021·2021-06-30

    FilmArray Pneumonia Panel diagnostic test kits recalled for false results

    BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.

    Product
    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1931-2021·2021-06-30

    FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results

    Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.

    Product
    FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2021·2021-06-30

    Medical Action Curved Hemostats recalled due to flaking metal risk

    Medical Action Industries is recalling curved hemostats distributed across 16 U.S. states due to a manufacturing defect causing potential metal flaking and discoloration.

    Product
    Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2021·2021-06-30

    OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.

    Product
    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
    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-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-1939-2021·2021-06-30

    OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.

    Product
    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
    Category
    Medical Device
    Distribution
    Distributed nationwide