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.

11351–11375 of 27206

  • ModerateFDA (Devices)·Z-2045-2024·2024-05-29

    MEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation

    Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.

    Product
    Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 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-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 (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-2106-2024·2024-05-29

    Wolf Medical Syringes Recalled for Non-Compliance with FDA Clearance

    Jiangsu Shenli Medical is recalling Wolf Medical 35 mL syringes because their piston sizes and configurations exceed the range cleared by the FDA 510(k) authorization.

    Product
    Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2024·2024-05-29

    Medline 20mL Non-Sterile Syringes Recalled for Configuration Non-Conformance

    Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 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-2061-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled Due to Manufacturing Specification Mismatch

    Medline non-sterile 5mL syringes (model 91829) are recalled because they were manufactured outside the scope of FDA-approved specifications. About 35,000 units are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2024·2024-05-29

    Medline 10ml Syringes Recalled for Exceeding FDA Clearance Range

    Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1249-2024·2024-05-29

    Price Chopper Fat Free Cottage Cheese with Pineapple Recalled for Undeclared Sugar

    HP Hood is recalling Price Chopper Fat Free Cottage Cheese with Pineapple 16oz tubs due to undeclared sugar. Affected products have Item # 54267 and specific production dates in May 2024.

    Product
    Price Chopper Fat Free Cottage Cheese with Pineapple Added 16oz plastic tub.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2056-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Model 91822 Recalled for Unapproved Configuration

    MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Unapproved Device Configurations

    Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 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-2066-2024·2024-05-29

    Non-sterile Syringes Recalled for Unapproved Specifications

    Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2024·2024-05-29

    Medline Syringes Recalled: Device Configuration Outside FDA Clearance Scope

    Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2116-2024·2024-05-29

    GMAX 60ML Non-Sterile Syringes Recalled for Design Non-Compliance

    Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M 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
  • CriticalFDA (Devices)·Z-1685-2024·2024-05-22

    Boston Scientific cardiac catheters recalled for delaminating polyurethane and guidewire advancement failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1665-2024·2024-05-22

    Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment

    Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1671-2024·2024-05-22

    Expo 5F Cardiac Catheters recalled due to polyurethane delamination

    Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1681-2024·2024-05-22

    Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues

    Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1657-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled for Material Delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0494-2024·2024-05-22

    Dietary Supplement Marketed as Unapproved Drug Without FDA Approval

    Stop Clopez Corp's Schwinnng Herbal Dietary Supplement Capsules were distributed worldwide via Amazon without FDA approval as a new drug. Consumers should discontinue use immediately.

    Product
    Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1641-2024·2024-05-22

    Boston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1661-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment

    Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states