The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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6201–6225 of 13512

  • 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-1865-2024·2024-05-29

    Philips dStream MR System Terminal Connection May Become Loose and Cause Fire

    Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.

    Product
    Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2024·2024-05-29

    Medline 10mL Syringes Recalled Due to Non-Conforming Device Configuration

    Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2024·2024-05-29

    FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch

    Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.

    Product
    Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2024·2024-05-29

    MRI System Mains Distribution Unit Connection Fire Risk

    Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.

    Product
    SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
    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 (Devices)·Z-2046-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope

    Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Offering Configurations Outside FDA Approved Clearance Scope

    Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations

    Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2024·2024-05-29

    GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance

    GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2024·2024-05-29

    Medline 20mL Non-Sterile Syringes Recalled for Design Specification Deviation

    Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2024·2024-05-29

    Philips Achieva 3.0T PET imaging device poses potential fire hazard

    A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.

    Product
    Achieva 3.0T TX for PET Model Number (REF): 781479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2024·2024-05-29

    Magnetic Resonance System Loose Terminal Connection May Cause Fire

    Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.

    Product
    MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2024·2024-05-29

    FDA recalls GMAX non-sterile syringes sold outside approved specifications

    FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.

    Product
    Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    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
  • HighFDA (Devices)·Z-1853-2024·2024-05-29

    Philips Intera 1.5T MRI System Mains Connection Defect Poses Fire Risk

    Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.

    Product
    Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
    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-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-1842-2024·2024-05-29

    MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk

    Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.

    Product
    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
    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-2100-2024·2024-05-29

    Disposable Luer Lock Syringes Recalled for Exceeding Cleared Specifications

    Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.

    Product
    Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing

    Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No
    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-1886-2024·2024-05-29

    Thyroid Autoantibody Test System Recalled for Falsely Elevated Results

    Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide