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.

12676–12700 of 53082

  • HighFDA (Devices)·Z-2078-2023·2023-07-12

    PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.

    Product
    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2023·2023-07-12

    Giraffe OmniBed neonatal incubator recall due to incorrect secondary latch installation

    GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.

    Product
    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V474000·2023-07-11

    Prevost H3-45 Turn Signal Light Failure Increases Crash Risk

    Prevost is recalling 2022-2024 H3-45 and H3-45 VIP vehicles because the right front turn signal light may fail when activated. Inoperative turn signals and hazard lights reduce visibility to other drivers and increase crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V475000·2023-07-11

    Prevost Recalls X3-45 Commuter Buses Due to Seat Bolt Loosening

    Prevost is recalling 2021 and 2023 X3-45 Commuter buses because a seat bolt may loosen, leaving the seat back unsecured and increasing crash injury risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V485000·2023-07-11

    2023 Toyota RAV4 Recalled for Improperly Installed Tire Valve Stems

    Gulf States Toyota is recalling 195 2023 Toyota RAV4 vehicles equipped with 17" black alloy wheels. The tire valve stems may be improperly installed or damaged, potentially causing air leakage, underinflation, and crash risk.

    Product
    TOYOTA — TOYOTA RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V471000·2023-07-10

    2023 BMW XM and 2024 X5-X7 vehicles recalled for knee air bag defect

    BMW of North America is recalling 2023 XM and certain 2024 X5, X6, and X7 vehicles because the knee air bag may not have been manufactured correctly and could fail to deploy during a crash. Dealers will replace the air bag free of charge.

    Product
    BMW — BMW X5, X6, XM, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E052000·2023-07-10

    Dana Spicer Driveshafts Recalled for Risk of Breaking Under Load

    Dana Incorporated is recalling specific Dana-Spicer driveshafts that can break under certain loading conditions, potentially causing a loss of drive power and increasing crash risk.

    Product
    POWER TRAIN:DRIVELINE:DRIVESHAFT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V468000·2023-07-07

    2023 Toyota Tundra Spare Tire Carrier May Detach Due to Insufficient Welds

    Toyota is recalling certain 2023 Tundra, Tundra Hybrid, and Sequoia Hybrid vehicles due to insufficiently welded spare tire carrier assemblies that may break and allow the spare tire to detach, increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA HYBRID, TUNDRA, SEQUOIA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V469000·2023-07-07

    Newmar motorhomes recalled for defective seat belt mounting brackets

    Newmar is recalling certain 2019–2023 motorhomes because modified seat belt mounting brackets can fail to properly restrain occupants in a crash, violating federal safety standards.

    Product
    NEWMAR — NEWMAR BAY STAR, BAY STAR SPORT, SUPER STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23239·2023-07-06

    woom ORIGINAL Kids' Bicycles Recalled Due to Fall Hazard

    woom Bikes USA recalls about 84,000 woom ORIGINAL children's bicycles from model years 2018–2021. The stem and handlebar can detach, causing riders to lose control and fall.

    Product
    woom ORIGINAL Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23772·2023-07-06

    Yamaha Model Year 2023 Golf Cars and PTVs Recalled for Crash and Death Hazards

    Yamaha is recalling about 11,000 Model Year 2023 Golf Cars, Personal Transportation Vehicles, and Umax models because the accelerator spring can become dislodged, preventing the accelerator pedal from returning to rest and posing crash, injury, and death hazards.

    Product
    Model Year 2023 Yamaha Golf Car, Personal Transportation Vehicles (PTV) and Umax
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2023·2023-07-05

    Exactech Ergo Impactor Handle Recalled for Component Dislodgement

    Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.

    Product
    Exactech Ergo Impactor Handle, Catalog #321-09-05.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2049-2023·2023-07-05

    LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects

    The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2036-2023·2023-07-05

    Vanta Implantable Neurostimulator May Become Unresponsive During Cardioversion

    Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.

    Product
    Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2020-2023·2023-07-05

    Orthopedic assembly screws with incorrect model number labeling and markings

    AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1010-2023·2023-07-05

    Compass USA recalls Fresh To You Chicken Filet Sandwich due to uncooked chicken

    Compass USA is recalling Fresh To You Chicken Filet Sandwich because the chicken was not cooked. Consumers who purchased this product should not consume it.

    Product
    Fresh To You Chicken Filet Sandwich. MGF0635. Net Wt. 8oz. Perishable - Keep Refrigerated. Manufactured By MG Foods, Oak Creek, WI 53154
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2002-2023·2023-07-05

    Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw

    B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.

    Product
    Perifix¿ / Epidural anesthesia kit (10 count carton)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0888-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations

    The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.

    Product
    StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1016-2023·2023-07-05

    Mott's Applesauce Recalled for Elevated Patulin Levels

    MOTTS LLP is recalling Mott's No Sugar Added Applesauce due to elevated patulin levels. The affected products have Best By dates of August 13-14, 2024, and were distributed across the U.S., Bermuda, and the Dominican Republic.

    Product
    Mott s no sugar added applesauce 6 pack 3.9 oz (111g) Containers 23.4 oz (666g). Individual units are packaged in plastic cups and placed in a cardboard sleeve of 6 sups with 12 sleeves to a case. Retail unit UPC is 14800000078 . Case label UPC is 10014800000075
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2004-2023·2023-07-05

    PushTracker E2 watch app may crash, disabling wheelchair motor controls

    Permobil's PushTracker E2 watch controls wheelchair power assist motors. The application may crash when running multiple processes, causing the motor to keep running and preventing users from stopping it using normal controls.

    Product
    PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2006-2023·2023-07-05

    Voalte Patient Safety software may fail to alert caregivers of safety changes

    Baxter's Voalte Patient Safety software may permanently stop sending caregiver alerts for critical patient protocols like bed exit and siderail changes. Affected versions V4.0.000 through V4.0.401 are used with Centrella Beds.

    Product
    Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2023·2023-07-05

    Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error

    Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2023·2023-07-05

    Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect

    Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.

    Product
    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Food)·F-1012-2023·2023-07-05

    Rudolphs OnYums Onion Snack Rings recalled for undeclared wheat and artificial colors

    Rudolphs OnYums Onion Snack Rings are recalled for undeclared wheat and artificial colors. Consumers with wheat allergies should not consume this product.

    Product
    Rudolphs OnYums Onion Flavored Snack Rings 3 oz. UPC 0-24622-57106-9 packaged in metallized film bags, 15 bags per case
    Category
    Food
    Distribution
    17 states