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.

11226–11250 of 27089

  • ModerateFDA (Devices)·Z-2118-2024·2024-05-29

    FDA Recalls GMAX Syringes Due to Unapproved Configuration

    Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2024·2024-05-29

    Non-Sterile Syringes Recalled Outside FDA-Cleared Size and Configuration Range

    Medline is recalling 820,400 non-sterile syringes (model 91832) because their sizes and configurations fall outside what was cleared by the FDA. The devices were not manufactured within the approved specifications.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2024·2024-05-29

    Prescription Drug Sirolimus Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Sirolimus 1mg tablets nationwide due to failed impurity and degradation specifications. The recall affects 1,176 bottles from lot H2200493 expiring 6/30/2025.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2024·2024-05-29

    GMAX SYR 60ML/LS Syringes Recalled for Non-Approved Specifications

    Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.

    Product
    Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2024·2024-05-29

    MEDLINE 5ML Non-Sterile Syringes Recalled for Unapproved Configurations

    MEDLINE non-sterile syringes (Model 91859) are being recalled because their sizes and configurations exceed the scope of the manufacturer's FDA 510(k) clearance. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2047-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Exceeding FDA-Cleared Specifications

    Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 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-2103-2024·2024-05-29

    Wolf Medical Syringes Recalled for Uncleared Size and Configuration Variants

    Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.

    Product
    Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Component: No
    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-2122-2024·2024-05-29

    GMAX Blue Syringes Recalled for Out-of-Range Design Configurations

    Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.

    Product
    Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2024·2024-05-29

    Non-sterile syringes recalled for manufacturing outside FDA-cleared specifications

    Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2024·2024-05-29

    Medline 20ML Non-Sterile Syringes Recalled for Non-Approved Configurations

    Jiangsu Shenli Medical is recalling Medline 20ML non-sterile syringes (Model 91863) because certain piston syringe sizes and configurations were not cleared under the firm's FDA 510(k). The affected units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2024·2024-05-29

    Nicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2044-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled for Configuration Exceeding FDA Clearance

    Jiangsu Shenli Medical Production is recalling MEDLINE non-sterile syringes because certain configurations exceed the scope approved by the FDA. The recalled syringes were distributed nationwide across multiple states.

    Product
    Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2024·2024-05-29

    Non-sterile syringes recalled for configurations exceeding FDA clearance

    Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2128-2024·2024-05-29

    MEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance

    MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2024·2024-05-29

    Medline 10ML Syringes Recalled Due to Regulatory Specification Non-Compliance

    Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2024·2024-05-29

    Medline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications

    Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2121-2024·2024-05-29

    GMAX SYR 10ML Control Syringes Recalled for Exceeding Device Specifications

    Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes because the device specifications exceed FDA-cleared limits. Approximately 348,800 units were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2065-2024·2024-05-29

    Medline non-sterile syringes recalled for unauthorized syringe sizes and configurations

    Medline non-sterile syringes (Model 91833) are being recalled because the manufactured syringe sizes and configurations do not match the company's regulatory clearance. Consumers should stop using the recalled lot numbers.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2063-2024·2024-05-29

    FDA Recalls Medline Non-Sterile Syringes for Regulatory Non-Compliance

    Medline has recalled approximately 325,500 non-sterile syringes (Model 91831) due to syringe sizes and configurations that fall outside FDA-cleared specifications. The syringes were distributed nationwide and manufactured by Jiangsu Shenli Medical Production Co., Ltd.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2024·2024-05-29

    MEDLINE Piston Syringes Recalled for Out-of-Range Specifications

    Jiangsu Shenli Medical Production recalled 1.7 million MEDLINE piston syringes because the devices' sizes and configurations exceed what was cleared by the FDA. The affected syringes were distributed nationwide across multiple states.

    Product
    Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2024·2024-05-29

    Medline non-sterile syringes recalled for exceeding cleared device specifications

    Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 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
  • ModerateFDA (Devices)·Z-2069-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled for Unapproved Sizes and Configuration

    Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six states.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide