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.

18601–18625 of 50407

  • HighFDA (Devices)·Z-0301-2022·2021-12-01

    Siemens Artis Q angiography systems may fail to deliver x-ray during procedures

    Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.

    Product
    Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2022·2021-12-01

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy

    The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.

    Product
    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
    Category
    Medical Device
    Distribution
    13 states
  • HighNHTSA·21V935000·2021-12-01

    Audi Recalls 2022 E-Tron GT Vehicles Due to Air Suspension Defect

    Volkswagen Group of America is recalling 2022 Audi E-Tron GT vehicles because a loose retaining ring on air suspension struts may compromise handling and increase crash risk.

    Product
    AUDI — AUDI E-TRON GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2022·2021-12-01

    Medtronic Wireless Recharger Model WR9200 Becomes Unresponsive on Improper Use

    Medtronic is recalling the Wireless Recharger Model WR9200 used with RestoreUltra and RestoreSensor neurostimulator implants. The recharger becomes unresponsive if charging instructions from the user guide are not followed correctly.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2022·2021-12-01

    CT Scanner Software Issue May Interrupt Diagnostic Workflows and Delay Diagnoses

    Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.

    Product
    SOMATOM Force with software syngo.CT VB20 Model #10742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V931000·2021-11-29

    Mercedes-Benz Recalls EQS and S-Class Models for Infotainment Distraction

    Mercedes-Benz is recalling 2021-2022 EQS and S-Class vehicles because the infotainment system may allow TV and internet use while driving, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580, EQS 450, S 500 4MATIC, S 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V930000·2021-11-26

    Autocar Recalls 2019-2020 Xpeditor Vehicles for Engine Stall Risk

    Autocar is recalling 2019-2020 Xpeditor vehicles with aftermarket power take-off systems because the engine may stall, increasing the risk of a crash.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V929000·2021-11-26

    Nova Bus Recalls 2021 LFS Buses for Door Software Defect

    Nova Bus is recalling 2021 LFS buses because software may cause the rear passenger door to open or close unexpectedly, posing an injury risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V927000·2021-11-25

    Lamborghini Recalls One 2021 Aventador SVJ Roadster for Oil Line Fire Risk

    Lamborghini is recalling one 2021 Aventador SVJ Roadster because improperly tightened oil line screws may detach, causing oil to leak onto hot components and increasing fire risk.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR SVJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0160-2022·2021-11-24

    Carolina Ingredients Beef Gravy Mix Recalled for Elevated Lead Levels

    Carolina Ingredients is recalling Beef Gravy Mix (product code N715025) due to elevated lead levels found in some samples after lab testing. All affected product was shipped to a customer in Georgia.

    Product
    Carolina Ingredients Beef Gravy Mix Non-allergen N715025 Net Wt. 50 lbs. Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0236-2022·2021-11-24

    Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues

    Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.

    Product
    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0165-2022·2021-11-24

    Carolina Ingredients Sweet Chipotle Seasoning Recalled for Possible Lead

    Carolina Ingredients is recalling Sweet Chipotle Seasoning due to possible lead contamination. The product was distributed to one customer in Georgia.

    Product
    Carolina Ingredients Sweet Chipotle Seasoning Mfr. By: Carolina Ingredients, LLC Rock Hill, SC 29730
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0237-2022·2021-11-24

    LOTRIMIN AF Jock Itch Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling LOTRIMIN AF Jock Itch Powder Spray (Miconazole nitrate 2%, 4.6 OZ cans) distributed nationwide due to manufacturing facility cGMP deviations where other lots were found to be contaminated with benzene.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2022·2021-11-24

    Sensis Diagnostic System UI Freeze Risk Without Regular System Reboots

    Siemens' Sensis diagnostic systems may experience partial UI freezing and fail to update vital signs display if not rebooted at least every 7 days per manufacturer instructions.

    Product
    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2022·2021-11-24

    LEEP PRECISION Integrated System may fail to coagulate during surgery

    CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.

    Product
    LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

    Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

    Product
    bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2022·2021-11-24

    Electrosurgical Generator Coagulation Function May Fail During Surgery

    CooperSurgical recalled 700 Quantum 2000 Electrosurgical Generators due to a hand switch coagulation function defect that may fail to operate during surgery, potentially requiring medical intervention to control intraoperative bleeding.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2022·2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·21V925000·2021-11-24

    RAM Pickup Trucks Side Air Bag Deployment Defect Recall

    Chrysler is recalling certain 2021-2022 RAM 2500 and 3500 pickup trucks and 2021 RAM 1500 Classic models. The side air bag curtain assemblies may deploy improperly due to incorrect gas pressure, increasing injury risk in a crash.

    Product
    RAM — RAM 2500, 3500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2022·2021-11-24

    Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling

    Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2022·2021-11-24

    LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure

    CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.

    Product
    LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V924000·2021-11-24

    Harley-Davidson Recalls 2021 Pan America Motorcycles for Seat Base Defect

    Harley-Davidson is recalling 2,689 2021 Pan America RA1250 motorcycles because the seat base may not be fastened properly, posing an injury risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON PAN AMERICA (RA1250)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0245-2022·2021-11-24

    Tinactin Tolnaftate Powder Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Powder Spray due to potential benzene contamination from cGMP deviations at the manufacturing facility. The recall affects approximately 2.8 million cans distributed nationwide and internationally.

    Product
    Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3…
    Category
    Drug
    Distribution
    Distributed nationwide