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.

8851–8875 of 53036

  • HighFDA (Devices)·Z-2086-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications

    Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2024·2024-05-29

    Philips Ingenia MRI Scanner Mains Distribution Unit Fire Risk Recall

    Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.

    Product
    Ingenia 1.5T S Model Number (REF): 781347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2024·2024-05-29

    Philips MR 5300 magnetic resonance systems' mains distribution unit may ignite

    Philips has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke in hospital technical rooms.

    Product
    MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2024·2024-05-29

    60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance

    Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.

    Product
    Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2024·2024-05-29

    Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope

    Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2024·2024-05-29

    Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2024·2024-05-29

    Philips Medical Device Recalled for Fire Hazard in Electrical Connection

    Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2024·2024-05-29

    Integra Cranial Access Kit Packaging Defects May Compromise Sterility

    Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.

    Product
    Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2024·2024-05-29

    Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard

    Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.

    Product
    Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2024·2024-05-29

    Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard

    Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.

    Product
    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V376000·2024-05-28

    Tesla seat belt warning light and chime may not activate

    Tesla is recalling certain 2012-2024 vehicles because the seat belt warning light and audible chime may not activate for an unbelted driver, failing FMVSS 208. A free over-the-air update fixes it.

    Product
    TESLA — TESLA MODEL S, MODEL X, MODEL 3, MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V374000·2024-05-28

    BYD Recalls Transit Buses Due to Incorrect Fuse Fire Risk

    BYD is recalling 2019-2023 transit buses because an incorrect fuse in the rearview mirror control switch may overheat and increase the risk of a fire.

    Product
    BYD — BYD K8M, K7M, C10M, K9S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V369000·2024-05-24

    VinFast VF8 airbags may contain inactive ignitors preventing deployment

    VinFast is recalling certain 2022-2024 VF8 vehicles because inactive ignitors may have been installed in the airbags, which can prevent them from deploying. 225 units affected.

    Product
    VINFAST — VINFAST VF 8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V368000·2024-05-24

    Lincoln Aviator rearview camera images may flicker near a cell phone

    Ford is recalling certain 2020-2024 Lincoln Aviator vehicles because electromagnetic interference from a cell phone can cause the rearview camera image to flicker or distort.

    Product
    LINCOLN — LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V371000·2024-05-24

    Mercedes-Benz Recalls 2023 AMG C43 Vehicles Due to Seat Wiring Defect

    Mercedes-Benz is recalling 2023 AMG C43 vehicles because incorrectly routed seat wiring may damage the harness, preventing seat air bags from deploying in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E039000·2024-05-23

    Nexxpro Recalls NEXX X.G10 Helmets for Inadequate Impact Protection

    Nexxpro is recalling NEXX X.G10 helmets in sizes M and S because they may lack a required carbon layer, failing to provide adequate protection in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V364000·2024-05-23

    Range Rover Sport rearview cameras may admit water and distort

    Land Rover is recalling certain 2018-2022 Range Rover Sport vehicles with a Surround Camera System because water may enter the rearview camera, blanking or distorting the image.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V367000·2024-05-23

    Rivian R1S R1T and EDV headlights may be improperly aimed

    Rivian is recalling certain 2023-2024 EDV, R1S and R1T vehicles because the headlights may be improperly aimed, failing FMVSS 108. 2,334 units are affected.

    Product
    RIVIAN — RIVIAN R1S, R1T, EDV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24239·2024-05-23

    TOPINCN Pool Drain Covers Recalled for Entrapment Hazard

    TOPINCN pool drain covers do not meet safety standards under the Virginia Graeme Baker Pool and Spa Safety Act, creating a risk of entrapment to swimmers and bathers. About 340 units sold online through Amazon from September 2022 through March 2024 are affected.

    Product
    TOPINCN Pool Drain Covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V366000·2024-05-23

    Chevrolet Colorado fitted with tires that do not match the label

    GM is recalling certain 2024 Chevrolet Colorado vehicles because incorrect tires may have been installed that do not match the tire label, and the TPMS may report inaccurately.

    Product
    CHEVROLET — CHEVROLET COLORADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2024·2024-05-22

    Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.

    Product
    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1792-2024·2024-05-22

    TriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect

    TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.

    Product
    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2024·2024-05-22

    MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility

    Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.

    Product
    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041;
    Category
    Medical Device
    Distribution
    Distributed nationwide