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.

22801–22825 of 50430

  • HighFDA (Devices)·Z-2425-2020·2020-07-01

    Zest Anchors Recalls Locator Overdenture Implant Systems Due to Abutment Defects

    Zest Anchors LLC is recalling Locator Overdenture Implant Systems because the abutments may be out of specification, potentially causing a gap between the implant and abutment.

    Product
    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V382000·2020-07-01

    2020-2021 Forest River Vengeance Trailers Landing Leg Spacing Defect Recall

    Forest River is recalling certain 2020-2021 Vengeance trailers because the fifth-wheel landing legs are not properly spaced, potentially allowing the fifth wheel to slip and puncture the trailer floor, increasing injury risk.

    Product
    FOREST RIVER — FOREST RIVER VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2020·2020-07-01

    Hocoma Lokomat Pro Recalled for Uncontrolled Body Weight Support Rope Movement

    Hocoma AG is recalling 494 Lokomat Pro units because a motor controller failure may cause the body weight support rope to move up or down in an uncontrolled way.

    Product
    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2020·2020-07-01

    Merge Healthcare Software Recall for Inaccurate Z-Score Calculations

    Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.

    Product
    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V384000·2020-07-01

    Volvo VNL and VNR Buses: Incorrect Axle Weight Rating Labels

    Volvo is recalling certain 2018–2021 VNL and VNR buses with incorrect Gross Axle Weight Rating labels on rear drive axles. Overloading could cause wheel hub failure and increase the risk of a crash.

    Product
    VOLVO — VOLVO VNR, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2020·2020-07-01

    GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms

    GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.

    Product
    CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1370-2020·2020-07-01

    Aurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling 1,440 bottles of Clozapine 100mg tablets because a consumer reported finding 50mg tablets in the 100mg bottles.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2020·2020-07-01

    Siemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues

    Siemens is recalling Atellica Solution IM1600 Analyzers because insufficient sample volumes may not be detected when using specific sample cups.

    Product
    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2428-2020·2020-07-01

    Providence Medical Technologies Recalls Ally Bone Screws Due to Dimensional Error

    Providence Medical Technologies is recalling 208 units of Ally Bone Screws due to a potential dimensional manufacturing error that poses a safety risk to patients.

    Product
    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20T012000·2020-06-30

    Bridgestone Recalls Mobile Crane Tires Due to Missing Safety Markings

    Bridgestone is recalling specific V-Steel tires for mobile cranes because they lack required DOT and safety markings, potentially leading to unsafe operating conditions.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V379000·2020-06-30

    BMW Recalls 2020-2021 7 Series Models Due to Child Seat Anchor Issue

    BMW is recalling 2020-2021 7 Series vehicles because the rear middle child seat tether anchor may be inaccessible, increasing injury risk in crashes.

    Product
    BMW — BMW 750LI, M760I, B7 ALPINA, 740LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V376000·2020-06-26

    Forest River Rockwood Trailers Recalled for Incorrect Weight Rating Labels

    Forest River is recalling 2020-2021 Rockwood trailers with incorrect Gross Axle Weight Rating information on their Federal Placards. This could allow operators to unknowingly overload the vehicle, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V377000·2020-06-26

    2021 Forest River Cherokee Wolf Pack Toyhauler Propane Routing Defect

    Forest River is recalling the 2021 Cherokee Wolf Pack toyhauler because the propane line may be routed around sharp edges, which can cause a leak and fire risk. Owners should contact Forest River at 1-260-499-2100 for a free repair.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE WOLF PACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20753·2020-06-25

    Costway Recalls Baby Strollers Due to Fall and Strangulation Hazards

    Costway is recalling about 16,000 double baby strollers because they violate federal safety standards, posing fall, entrapment, and strangulation risks to children.

    Product
    Baby Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2020·2020-06-24

    GE Healthcare Recalls Giraffe Incubators with Servo Oxygen Module

    GE Healthcare is recalling Giraffe Incubators with Servo Oxygen modules because they may deliver different oxygen levels than displayed.

    Product
    Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V373000·2020-06-24

    Toyota Recalls 2019-2020 RAV4 Models for Electric Power Steering Defect

    Toyota is recalling 2019-2020 RAV4 and 2020 RAV4 Hybrid vehicles because water may enter the steering gear box, causing a loss of electric power steering assist.

    Product
    TOYOTA — TOYOTA RAV4, RAV4 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2020·2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.

    Product
    Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2020·2020-06-24

    Siemens MAMMOMAT Revelation Mammography System Recalled for Biopsy Removal Limitation

    Siemens is recalling MAMMOMAT Revelation mammography systems because a software limitation may make it difficult to remove the vacuum biopsy system if an exam is interrupted.

    Product
    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V368000·2020-06-24

    Vac-Tron Recalls 2020 Vacuum Excavator Trailers for Missing Reflectors

    Vac-Tron is recalling 100 units of 2020 vacuum excavator trailers because they may be missing rear and rear-side reflex reflectors, which reduces visibility and increases crash risk.

    Product
    VAC-TRON — VAC-TRON LPSDT, MINICOMBO, CVGT, CVGTLC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2020·2020-06-24

    Stryker Locking Screw Recall Due to Potential Sterility Compromise

    Stryker is recalling specific lots of Locking Screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes

    Resource Optimization & Innovation LLC is recalling Regard SRHS GIC Port A Cath devices because holes in the packaging may compromise the sterile field.

    Product
    Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2020·2020-06-24

    Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

    Stryker is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

    Product
    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0994-2020·2020-06-24

    Captain Rusty's Smoked Salmon Dip Recalled for Undeclared Milk Allergen

    Captain Rusty's Seafood Products LLC is recalling Smoked Salmon Dip due to undeclared milk, a major allergen, discovered during a routine inspection.

    Product
    Captain Rusty's Smoked Salmon Dip, A Taste of the Pacific Coast, Keep Refrigerated, 16 oz.
    Category
    Food
    Distribution
    0 states