The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

11301–11325 of 27206

  • 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-2094-2024·2024-05-29

    Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes

    Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No
    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-2098-2024·2024-05-29

    Medline non-sterile syringes recalled for out-of-specification piston configurations

    Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
    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-1868-2024·2024-05-29

    Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor

    Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2024·2024-05-29

    Medline Syringes Recalled for Out-of-Specification Design Configuration

    Medline 10ml syringes in lots 63721060001, 63721110001, 63722120002, and 63723070001 are recalled because their sizes and configurations exceed FDA-approved specifications. No injuries reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2024·2024-05-29

    FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration

    Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2024·2024-05-29

    GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance

    Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.

    Product
    Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M 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-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-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-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
  • HighFDA (Food)·F-1251-2024·2024-05-29

    Geissler's Philadelphia Sushi Roll Recalled for Undeclared Milk Allergen

    Geissler's Supermarket is recalling Philadelphia Avo or Cucumber Classic Roll sushi due to undeclared milk allergen. Affected products were distributed in Connecticut and Massachusetts with sell-by dates 3/27/2024 and 3/28/2024.

    Product
    Geissler's Supermarket Philadelphia Avo or Cucumber Classic Roll (sushi roll) Ingredients read in part: "***INGREDIENTS: SMOKED SALMON, CREAM CHEESE, AVOCADO, CUCUMBER, RICE. NORI. WHITE STEAMEDRICE. VINEGAR. SUGAR. SALT. LEMON. MIRIN.WASABI. GINGER. WATER, SOYSAUCE (WHEAT, SOYB
    Category
    Food
    Distribution
    2 states
  • 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-2050-2024·2024-05-29

    Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation

    Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2024·2024-05-29

    Philips MRI System Recalled for Potential Fire in Power Distribution Unit

    Philips is recalling 2 Achieva 1.5T MRI systems worldwide due to a potential loose connection in the power distribution unit that could cause smoke or fire in hospital technical rooms.

    Product
    Achieva 1.5T Initial system Model Number (REF): 781178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2024·2024-05-29

    Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk

    Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.

    Product
    Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2024·2024-05-29

    Yamaha Surface Mounter Equipment Recalled for Missing Laser Safety Certification Labels

    Yamaha is recalling certain surface mounter equipment models because they lack required certification labels for laser safety compliance under FDA regulations.

    Product
    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounte
    Category
    Other
    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
  • ModerateFDA (Devices)·Z-1889-2024·2024-05-29

    Cerene Cryotherapy Device recall: missing error code in troubleshooting table

    Channel Medsystems is recalling the Cerene Cryotherapy Device because error code 003 is missing from the device's troubleshooting documentation, which could prevent clinicians from properly diagnosing errors during use.

    Product
    Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Unapproved Configuration

    Medline 10mL non-sterile syringes have been recalled because their piston size and configuration fall outside the range cleared by FDA. The recall affects 7,000 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2024·2024-05-29

    GMAX SYR 35ML Non-Sterile Syringes Recalled for Regulatory Non-Compliance

    The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.

    Product
    Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2089-2024·2024-05-29

    FDA Recalls Medline Syringes Manufactured Outside Approved Specifications

    Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2024·2024-05-29

    GMAX Syringes Recalled for Manufacturing Outside FDA-Cleared Specifications

    Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.

    Product
    Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide