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.

Filters

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

21626–21650 of 40339

  • HighFDA (Devices)·Z-0593-2019·2018-12-19

    St. Jude Medical DBS Leads Recalled for Incorrect Electrode Material

    St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.

    Product
    St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Puncture Risk

    CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.

    Product
    CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0588-2019·2018-12-19

    GE LOGIQ E10 Ultrasound System Recalled for Potential Burn Injury

    GE Healthcare is recalling 103 LOGIQ E10 Ultrasound Systems because a trans-esophageal probe may overheat, posing a risk of burn injury to patients.

    Product
    GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2019·2018-12-19

    Zimmer Biomet Recalls Orthopedic Stems Due to Potential Labeling Error

    Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.

    Product
    Comprehensive Mini Stem, Item No. 113631:
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0572-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0595-2019·2018-12-19

    Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates

    Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.

    Product
    Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0565-2019·2018-12-19

    CIVCO Biopsy Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.

    Product
    CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0575-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.

    Product
    CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0600-2019·2018-12-19

    Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk

    Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.

    Product
    AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled Due to Missing Product Labeling

    CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0604-2019·2018-12-19

    Binding Site Human IgM Kit Recalled for Calibration Curve Validation Issues

    The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0592-2019·2018-12-19

    Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall

    Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.

    Product
    IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2019·2018-12-19

    CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects

    CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.

    Product
    SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0570-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0594-2019·2018-12-19

    Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards

    Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.

    Product
    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0573-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.

    Product
    CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0574-2019·2018-12-19

    CIVCO Needle Guide Bracket Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.

    Product
    CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0602-2019·2018-12-19

    Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear

    Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2019·2018-12-19

    CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues

    CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.

    Product
    SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0569-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Labeling Defects

    CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0599-2019·2018-12-19

    Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage

    Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.

    Product
    AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2019·2018-12-19

    CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.

    Product
    CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0596-2019·2018-12-19

    BioFlo PICC Recall Issued for Incorrect Expiration Date Labeling

    Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.

    Product
    BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0576-2019·2018-12-19

    CIVCO Sales Demo Kit Recalled for Missing Product Labeling

    CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.

    Product
    CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
    Category
    Medical Device
    Distribution
    0 states