The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

18326–18350 of 50406

  • HighFDA (Devices)·Z-0440-2022·2022-01-05

    Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias

    Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.

    Product
    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2022·2022-01-05

    VIDAS Clostridium Difficile GDH test substrate error causes test failure

    bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.

    Product
    VIDAS Clostridium Difficile GDH, REF 30125-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2022·2022-01-05

    Medical Device Aberrometer Systems Affected by Remote Code Execution Vulnerability

    AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.

    Product
    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
    Category
    Medical Device
    Distribution
    47 states
  • HighCPSC·22043·2022-01-05

    CRT Motor Youth All-Terrain Vehicles Recalled for Crash Hazard

    CRT Motor is recalling about 100 youth ATVs sold at Motorsports Planet because they do not meet mandatory safety requirements and can exceed maximum speed, increasing crash risk.

    Product
    CRT Motor Youth All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2022·2022-01-05

    da Vinci SP Surgical System Software Energy Delivery Defect

    Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.

    Product
    da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2022·2022-01-05

    Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2022·2022-01-05

    SterRx Succinylcholine Chloride Injection Recalled for Sterility Assurance

    SterRx is recalling Succinylcholine Chloride Injection 20 mg/mL vials (1,000 mL) distributed nationwide due to lack of assurance of sterility. The 3,540 affected bags may pose a risk to patients receiving this injectable drug.

    Product
    Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2022·2022-01-05

    VIDAS diagnostic test for C. difficile recalled due to substrate defect

    bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.

    Product
    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2022·2022-01-05

    Karl Storz Endoscope Sterilization Trays Instructions for Use Updated

    Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.

    Product
    Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID…
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-0353-2022·2022-01-05

    Raw Tuna at Meat Counter Recalled for High Histamine Levels

    Sant' Elia Operations is recalling raw tuna sold at meat counters in Wisconsin because samples tested above 50 ppm histamine, which can cause illness if consumed.

    Product
    Tuna, raw sold at meat counter and wrapped in butcher paper at point of purchase.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0421-2022·2022-01-05

    FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation

    Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.

    Product
    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0444-2022·2022-01-05

    Catalys Precision Laser System recalled for remote code execution vulnerability

    AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.

    Product
    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0420-2022·2022-01-05

    Ultimum Hemostasis Introducer devices recalled due to manufacturing error

    Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.

    Product
    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure

    SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.

    Product
    PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2022·2022-01-05

    VIDAS Lyme diagnostic test device recalled due to substrate error

    bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.

    Product
    VIDAS Lyme IgG II (LYM), REF 417401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2022·2022-01-05

    Speech Generation Device Charging Components Recalled for Fire and Electric Shock Hazard

    Forbes Rehab Services is recalling Monoprice charging cables and iClever charging bricks for ProSlate Speech Generation Devices due to fire and electric shock risks if cables are damaged or charging occurs near moisture.

    Product
    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2022·2022-01-05

    VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

    bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

    Product
    VIDAS Mumps IgG (MPG), REF 30218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2022·2022-01-05

    VIDAS procalcitonin diagnostic test substrate error causes testing delays

    Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.

    Product
    VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2022·2022-01-05

    VIDAS Estradiol II Test Device Recalled Due to Substrate Error

    bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.

    Product
    VIDAS Estradiol II, REF 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2022·2022-01-05

    VIDAS Measles IgG Test Kit Recalled Due to Substrate Error

    bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS Measles IgG (MSG), REF 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22044·2022-01-05

    Native Creation Small Wool Sweaters Recalled for Lead Paint on Zipper

    Native Creation is recalling approximately 170 small wool sweaters for children sizes 0 to 8 because the zipper pull contains lead paint that exceeds federal limits and poses a toxic ingestion risk to young children.

    Product
    Native Creation Small Wool Sweaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0355-2022·2022-01-05

    Giant Eagle Diced Green Peppers Recalled for Listeria Contamination

    Giant Eagle, Inc. is recalling frozen diced green peppers (10 oz., Best By 10/14/2023) distributed to stores in Maryland, Pennsylvania, West Virginia, Ohio, and Indiana because the product tested positive for Listeria monocytogenes.

    Product
    Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case , Best By 10/14/2023 .
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·22V002000·2022-01-04

    LGS Industries Recalls 2014-2021 Trailers with Electric Rear Door Winch Defect

    LGS Industries is recalling 2014-2021 trailers because the electric rear door winch cable may break, allowing the door to fall open and increasing injury risk.

    Product
    LGS INDUSTRIES — LGS INDUSTRIES SHADOW, PREMIER RACE, CARGO SPORT, JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide