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-2074-2024·2024-05-29

    Medline non-sterile syringes recalled for exceeding 510(k) clearance scope

    Jiangsu Shenli Medical recalled 18,900 Medline non-sterile syringes (Model 91842) because their sizes and configurations exceed the FDA's approved scope under the firm's 510(k) clearance.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 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-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-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-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
  • 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-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 (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-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-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-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-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-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-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 (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-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 (Drugs)·D-0502-2024·2024-05-29

    Prescription eye drops recalled for particulate matter contamination

    Sun Pharmaceutical recalls Xelpros latanoprost eye drops (Lot HAD3383A) due to particulate matter contamination detected during release testing. Affected bottles were distributed in Texas and Pennsylvania.

    Product
    XELPROS — XELPROS (LATANOPROST)
    Category
    Drug
    Distribution
    2 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-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-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
  • 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
  • SevereFDA (Devices)·Z-1672-2024·2024-05-22

    Expo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure

    Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in catheters distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1664-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling specific batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The affected catheters may not function properly during angiographic procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1669-2024·2024-05-22

    Expo 5F Selective Angiographic Cardiac Catheters: Guidewire Advancement Failure Risk

    Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states