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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16451–16475 of 40248

  • ModerateFDA (Devices)·Z-3006-2020·2020-09-30

    Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference

    Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.

    Product
    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3001-2020·2020-09-30

    OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing

    OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.

    Product
    CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3002-2020·2020-09-30

    OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes

    OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.

    Product
    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3003-2020·2020-09-30

    OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes

    OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.

    Product
    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3004-2020·2020-09-30

    DNA Genotek PrepIT Q2A Kit Recalled for Expired Reagents

    DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.

    Product
    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2965-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.

    Product
    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2020·2020-09-23

    Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue

    Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2953-2020·2020-09-23

    Integra LifeSciences Recalls 13 ft Handpiece Cables for Dermatome Sets

    Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.

    Product
    13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2020·2020-09-23

    Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

    Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

    Product
    AVANOS MIC-KEY SF Gastrostomy Feeding Tube
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2020·2020-09-23

    Integra Padgett Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

    Product
    Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2960-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Backwards Crimped Wire

    Terumo is recalling three Ultrasonic Air Sensors because a crimped wire was installed backwards, potentially causing false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2020·2020-09-23

    Novarad Recalls NovaPACS Diagnostic Viewer Software Due to Image Placement Error

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software because the cross-localization feature may inaccurately place reference lines on asymmetrical images.

    Product
    NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2978-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2961-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect

    Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2979-2020·2020-09-23

    Life Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software

    Life Technologies is recalling the TaqPath RT-PCR COVID-19 Kit due to software issues that may cause invalid, inconclusive, or false test results.

    Product
    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.

    Product
    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2952-2020·2020-09-23

    Longhorn PrimeStore Molecular Transport Medium Tubes Recalled for Cyanide Risk

    Longhorn Vaccines and Diagnostic is recalling PrimeStore Molecular Transport Medium tubes because the solution may produce cyanide gas when exposed to bleach.

    Product
    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2020·2020-09-23

    Integra Padgett Electric Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 2 units of the Padgett Electric Dermatome Set because the handpiece cable melts after sterilization.

    Product
    Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2963-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance

    Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.

    Product
    Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX…
    Category
    Medical Device
    Distribution
    Distributed nationwide