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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

20001–20025 of 40124

  • HighFDA (Devices)·Z-2116-2019·2019-08-07

    Burlington Medical Recalls Lead Apron Products Due to Inadequate Radiation Protection

    Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.

    Product
    2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2019·2019-08-07

    Burlington Medical Recalls Frontal Stretch Buckle Closure Aprons

    Burlington Medical is recalling nine Frontal Stretch Buckle Closure Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2019·2019-08-07

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.

    Product
    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2109-2019·2019-08-07

    Burlington Medical Frontal Support Belt Apron Recalled for Inadequate Radiation Protection

    Burlington Medical is recalling six Frontal Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2019·2019-08-07

    GE Senographe Pristina Mammography Systems Recalled for Biopsy Positioner Slippage

    GE Healthcare is recalling 82 Senographe Pristina mammography systems because the biopsy positioner may slip when the gantry is rotated during a procedure.

    Product
    GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2019·2019-08-07

    Burlington Medical Recalls Frontal Quick Drop OR Aprons Due to Radiation Risk

    Burlington Medical is recalling 23 Frontal Quick Drop OR Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Arterial Thermistor

    Terumo is recalling 16 Capiox NX19 Oxygenators with a non-functioning arterial thermistor component. The units were distributed in Michigan, Japan, and Belgium.

    Product
    Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2125-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling 48 radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.

    Product
    Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2019·2019-08-07

    Burlington Medical Recalls Frontal Apron Velcro Closures Due to Radiation Protection Concerns

    Burlington Medical is recalling 104 Frontal Apron Velcro Closures because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM Product Usage: Products are designed to protect healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 2,190 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.

    Product
    Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP Product Usage: Products are designed to protect healthcare workers against scatter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2019·2019-08-07

    Wilson-Cook Medical Recalls Acuject Variable Injection Needles

    Wilson-Cook Medical is recalling Acuject Variable Injection Needles due to a potential for occluded needles. The affected units were distributed to China.

    Product
    Acuject Variable Injection Needle
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2132-2019·2019-08-07

    GE Pristina Serena Breast Biopsy Accessory Recalled for Slippage Risk

    GE Healthcare is recalling 16 Pristina Serena breast biopsy accessories because the positioner may slip when the machine rotates during a procedure.

    Product
    GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2019·2019-08-07

    Burlington Medical Recalls Full Wrap Support Belt Aprons Due to Radiation Risk

    Burlington Medical is recalling 51 Full Wrap Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.

    Product
    1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2019·2019-08-07

    Burlington Medical Recalls Seven Peak Vests Due to Inadequate Radiation Protection

    Burlington Medical is recalling seven Peak Vests because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

    Product
    Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Vests Due to Inadequate Shielding

    Burlington Medical is recalling 22 radiation protection vests because the protective material may provide inadequate shielding against scatter radiation.

    Product
    Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM Product Usage: Products are designed to protect healthcare workers against scatter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 23 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing health risks for users.

    Product
    Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2019·2019-08-07

    Teleflex Recalls Rusch EasyCath Kits Due to Sterility Concerns

    Teleflex Medical is recalling 3,700 Rusch EasyCath Kits because they may not be sterile. The kits were distributed nationwide to eight states.

    Product
    Rusch EasyCath Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2019·2019-08-07

    Burlington Medical Recalls 310 Full Wrap Vests and Kilts for Radiation Protection Defects

    Burlington Medical is recalling 310 two-piece full wrap vests and kilts because the protective material may provide inadequate shielding against scatter radiation.

    Product
    2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2019·2019-08-07

    Inovo Single Luman Conserver Recalled for Potential Pressure Gauge Dislodgement

    Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.

    Product
    Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 210 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.

    Product
    Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Kilts Due to Inadequate Shielding

    Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding against scatter radiation.

    Product
    Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2056-2019·2019-08-07

    Agfa DR 800 Digital Radiography System Recalled for Image Mismatch

    Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2019·2019-08-07

    A&E Medical Ultra-Flex Pacing Wire Recalled for Instruction Updates

    Alto Development Corp is recalling Ultra-Flex MYO/Wire pacing wires to update instructions for use to ensure consistency with the M-21 loop electrode.

    Product
    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2019·2019-08-07

    Philips Recalls Azurion X-ray Systems Due to Software Defect

    Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.

    Product
    Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2019·2019-08-07

    Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits

    Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.

    Product
    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative…
    Category
    Medical Device
    Distribution
    1 state