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.

8776–8800 of 53036

  • 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
  • HighFDA (Devices)·Z-2104-2024·2024-05-29

    Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance

    Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.

    Product
    Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2024·2024-05-29

    Medline 10mL Syringes Recalled for Manufacturing Outside Approved Specifications

    Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2024·2024-05-29

    Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard

    Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.

    Product
    SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2024·2024-05-29

    Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope

    Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled for Being Outside Cleared Specifications

    Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2024·2024-05-29

    Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage

    Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.

    Product
    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2024·2024-05-29

    Medical MR System Electrical Terminal Connection May Create Fire Hazard

    A Philips Achieva 3.0T for PET MR diagnostic system (Serial 43006) may have a loose mains distribution unit terminal that could overheat and cause smoke or fire.

    Product
    Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
    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-1875-2024·2024-05-29

    Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing

    Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.

    Product
    Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2024·2024-05-29

    Philips Incisive CT Scanner Metal Mounting Box May Expel Fragments

    A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.

    Product
    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2024·2024-05-29

    Scopis ENT Navigation Software Contains Visual Guidance Alignment Error

    Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.

    Product
    8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0505-2024·2024-05-29

    Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

    Preferred Pharmaceuticals is recalling 66 bottles of Duloxetine 30mg capsules (Lot J2022G) due to manufacturing deviations that resulted in N-nitroso-duloxetine impurity above FDA limits.

    Product
    Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1816-2024·2024-05-29

    Yamaha Optical Inspection Systems Recalled for Missing Laser Safety Certification Label

    Yamaha Motor Corporation is recalling 67 Optical Inspection System units (models YSi-V, YSi-V(HS2), YRi-V) distributed nationwide for not bearing the required laser safety certification label.

    Product
    Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2024·2024-05-29

    Non-sterile Piston Syringes Distributed Outside FDA-Approved Specifications

    Medline piston syringes (Model 83083) manufactured by Jiangsu Shenli are being recalled because their sizes and configurations fall outside FDA-approved specifications. Approximately 494,000 units are affected across the United States.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2024·2024-05-29

    Medical Imaging System Recalled Due to Fire Risk from Loose Connection

    Philips has recalled 81 Marlin 1.5T MR diagnostic systems due to a loose g-MDU terminal connection that may create a fire hazard in hospital technical rooms.

    Product
    Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2024·2024-05-29

    MEDLINE syringes recalled for sizes outside FDA clearance

    MEDLINE is recalling 700 non-sterile 10ML syringes because their piston sizes and configurations exceed the range approved by FDA. No illnesses have been reported. Consumers should stop using these syringes.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 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
  • HighNHTSA·24V379000·2024-05-29

    Karma Revero vehicles recalled for intermittent front turn signal failure

    Karma Automotive is recalling 2020-2022 Revero models because a communication error may cause front turn signals to fail intermittently, increasing crash risk.

    Product
    KARMA — KARMA REVERO GTS, REVERO GS-6, REVERO GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2024·2024-05-29

    Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation

    Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2024·2024-05-29

    GMAX SYR 5ML syringes recalled for unapproved piston configurations

    FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.

    Product
    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2024·2024-05-29

    GMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance

    The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2024·2024-05-29

    Wolf Medical Syringes Recalled for Exceeding Approved Specifications

    Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.

    Product
    Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide