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.

20751–20775 of 50413

  • HighNHTSA·21V228000·2021-04-01

    Mercedes-Benz Recalls 2021 E-Class Models for Parking Sensor Defect

    Mercedes-Benz is recalling 2021 E350, E450, and AMG E63 vehicles because the parking control unit may fail to display the rearview camera or detect objects, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, E 450, AMG E63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V227000·2021-04-01

    2021 International Trucks Recalled for Air Brake Check Valve Manufacturing Defect

    Navistar recalls 2021 International trucks for defective air brake check valves that may cause unintended brake application and increase crash risk. The SC-3 valve's retainer is not properly seated.

    Product
    INTERNATIONAL — INTERNATIONAL RH, LT, HV, MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2021·2021-03-31

    Getinge Operating Table System Recalled for Hydraulic Leakage Risk

    Getinge Group Logistics America, LLC is recalling 4,288 Operating Table Systems due to a potential hydraulic leakage that could cause unintended table movement.

    Product
    Operating Table System
    Category
    Medical Device
    Distribution
    41 states
  • HighNHTSA·21V225000·2021-03-31

    Harley-Davidson motorcycles recalled for faulty headlight bulbs and visibility loss

    Harley-Davidson is recalling 2019-2021 Sportster motorcycles and replacement headlight assemblies because the glass bulb may fail, causing loss of both high and low beams and increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XL1200NS, XL1200C, XL883N, XL883L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect

    Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.

    Product
    VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21V224000·2021-03-31

    2021 Porsche Macan recalled for loose shock absorber screw connections

    Certain 2021 Porsche Macan models have improperly tightened screw connections on shock absorbers, which could compromise braking and vehicle control. Porsche will repair the connections free of charge.

    Product
    PORSCHE — PORSCHE MACAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2021·2021-03-31

    Stryker S-Series Equipment Management System Recall for Brake Disengagement Risk

    Stryker is recalling S-Series Equipment Management Systems because capacitive touch controls may disengage when electrocautery devices are in use.

    Product
    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2021·2021-03-31

    Olympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury

    Olympus is recalling 1,564 TJF-Q190V duodenoscopes and accessories worldwide due to complaints of mucosal injury associated with the forceps elevator region.

    Product
    Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0351-2021·2021-03-31

    Taylor Farms Recalls Tuna Salad Croissant Sandwiches for Undeclared Soy

    Taylor Farms Northwest is recalling 577 units of Tuna Salad Croissant Sandwiches because the product contains soy lecithin that is not declared on the label.

    Product
    Item #140952, Tuna Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 7.8 OZ (221g). UPC 0 30223 11097 2. The label is read in parts: "***CHICKEN SALAD…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1281-2021·2021-03-31

    RayCare 3B Oncology Software Recalled for Data Loss During Upgrade

    RaySearch Laboratories AB is recalling RayCare 3B software because patient messages may be lost when upgrading from RayCare 2.

    Product
    RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2021·2021-03-31

    Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking

    Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.

    Product
    RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0350-2021·2021-03-31

    Taylor Farms Recalls Chicken Salad Croissant Sandwiches for Undeclared Soy

    Taylor Farms Northwest is recalling Chicken Salad Croissant Sandwiches because the product contains soy lecithin that is not declared on the label.

    Product
    Item #140946, Chicken Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 7.8 OZ (221g). UPC 0 30223 11099 6. The label is read in parts: "***CHICKEN SALAD…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0352-2021·2021-03-31

    Buc-ee's Butter Toffee Almonds Recalled for Peanut Mislabeling

    Lehi Valley Trading Co is recalling Buc-ee's Butter Toffee Almonds because the product contains peanuts but is labeled as almonds.

    Product
    Buc-ee's Butter Toffee Almonds, 12 oz., packaged in clear zip top bag with stickered label, UPC: 0 9524842002 4, Manufactured and packaged at Lehi Valley Trading Company 4955 . McKellips Rd, Mesa, AZ 85215. branded and statement on label "Distributed by Buc-ee's LTD. 327 FM 2004…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1298-2021·2021-03-31

    Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns

    Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.

    Product
    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous Renal Replacement Therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2021·2021-03-31

    Bard Marquee Biopsy Instruments Recalled for Detaching Switch

    Bard Peripheral Vascular Inc is recalling Marquee Disposable Core Biopsy Instruments because the penetration depth switch may detach during use.

    Product
    BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1299-2021·2021-03-31

    Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results

    Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.

    Product
    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2021·2021-03-31

    Mizuho Operating Table Hand Control Units Recalled for Sliding Risk

    Mizuho OSI is recalling 26 operating table hand control units because they may cause the tabletop to slide in the opposite direction, potentially delaying surgical procedures.

    Product
    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1287-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0349-2021·2021-03-31

    Taylor Farms Egg Salad Croissant Sandwich Recalled for Undeclared Soy

    Taylor Farms is recalling 701 units of Egg Salad Croissant Sandwiches in Idaho, Oregon, and Washington because the label fails to declare soy lecithin.

    Product
    Item #140804, Egg Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 6.6 OZ (187g). UPC 0 30223 10915 0. The label is read in parts: "***Egg Salad Croissant…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1285-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0426-2021·2021-03-31

    Mindo Coffee Toffee Chocolate Bar Recalled for Undeclared Milk

    Mindo Chocolate Makers LLC is recalling Coffee Toffee Chocolate Bars due to undeclared milk, a major allergen. The recall covers 2,187 bars sold in Michigan and online.

    Product
    Mindo COFFEE TOFFEE CHOCOLATE BAR, 75 gram / 2.65oz UPC code 805993900527. Also sold in 12 count and 6 count cartons
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1286-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1283-2021·2021-03-31

    In2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use

    In2Bones is recalling 60 units of Shannon Percutaneous Burrs due to manufacturing non-conformity that may cause the burr to break during surgery.

    Product
    In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide