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.

6326–6350 of 26654

  • SevereFDA (Drugs)·D-0300-2025·2025-04-02

    SinuCleanse Nasal Saline Packets Recalled for Bacterial Contamination

    SinuCleanse Premixed Saline Packets sold nationwide are being recalled due to contamination with Staphylococcus aureus, a bacterium that can cause infection.

    Product
    SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0669-2025·2025-04-02

    Glicks Dark Chocolate Conettos recalled for undeclared milk allergen

    Kenover Marketing Corp. is recalling Glicks Dark Chocolate Conettos due to an undeclared milk allergen. The product was distributed across multiple states. Consumers with milk allergies should not consume it.

    Product
    Glicks Dark Chocolate Conettos, 2.47 oz., Plastic Bag, 24 packages per case
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0672-2025·2025-04-02

    Wangzhine Hot Pot Sauce recalled for undeclared wheat and soy allergens

    Liaoning Cheng Da (USA) Inc is recalling Wangzhine branded Hot Pot Sauce due to undeclared wheat and soy allergens. The recall affects 3,650 cases distributed to 5 direct accounts in California.

    Product
    Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0299-2025·2025-04-02

    SinuCleanse Nasal Wash System Recalled for Bacterial Contamination

    Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System nationwide due to bacterial contamination with Staphylococcus aureus. Affected lot number is 024122661Al with expiration date 12/2027.

    Product
    SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1396-2025·2025-04-02

    CVAC Aspiration System Requires Labeling Update for Pressure Risk

    The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.

    Product
    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0663-2025·2025-04-02

    Jinga Glass Noodles Recalled for Undeclared Egg Allergen

    HAR Maspeth Corp. is recalling Jinga Glass Noodles for containing undeclared egg. The product, distributed across the Northeast and Midwest, poses a risk to consumers with egg allergies.

    Product
    Jinga Glass Noodles with vegetables 8 oz. and 12 oz.
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0673-2025·2025-04-02

    Wangzhine Hot Pot Sauce Recalled for Undeclared Wheat and Soy Allergens

    Wangzhine branded Hot Pot Sauce (SPICY) is recalled for undeclared Wheat and Soy allergens. The affected product poses a risk to consumers with these allergies.

    Product
    Wangzhine branded Hot Pot Sauce (SPICY); Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001382
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0292-2025·2025-04-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination

    A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0297-2025·2025-04-02

    Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns

    QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2025·2025-04-02

    Medline Procedure Kits With Defective Syringes Recalled Nationwide

    Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.

    Product
    Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2025·2025-04-02

    Cysto Pack Procedure Trays Recalled Due to Sterility Assurance Issues

    American Contract Systems, Inc. is recalling 800 units of Cysto Pack procedure trays (Model BHCY31E) distributed in Arizona due to sterility assurance concerns.

    Product
    Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1429-2025·2025-04-02

    Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect

    Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.

    Product
    namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0294-2025·2025-04-02

    Testosterone Gel Recalled Nationwide Due to Benzene Contamination

    Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2025·2025-04-02

    Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment

    A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 units distributed nationwide are affected.

    Product
    Baxter Mobile column TruSystem 7500 U, Product Code 1730720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode

    Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.

    Product
    Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2025·2025-04-02

    Medline procedure kits recalled for syringe quality defects

    Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.

    Product
    Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage

    Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0298-2025·2025-04-02

    Babyganics Mineral Sunscreen Recalled for Failed Stability Specifications

    Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.

    Product
    babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment

    Baxter is recalling the TruSystem 7500 Hybrid due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0664-2025·2025-04-02

    Coca-Cola Original Taste cans recalled for foreign plastic object contamination

    Great Lakes Coca-Cola Distribution is recalling Coca-Cola Original Taste 12 oz. cans distributed in Illinois and Wisconsin due to a foreign plastic object. Consumers should stop consumption and dispose of affected products.

    Product
    Coco-Cola Original Taste, 12 Fl Oz. (355mL). Can UPC 0 49000-00634 6. 12-can pack UPC 0 49000-02890 4. Canned Under Authority of the Coca-Cola Company, Atlanta, GA 30313.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1464-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Quality Defects

    Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2025·2025-04-02

    Medline procedure kits with plastic syringes recalled for leaks and breakage

    Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2025·2025-04-02

    Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels

    Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.

    Product
    Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2025·2025-04-02

    Baxter TruSystem 7500 U Medical Device Software Malfunction Recall

    Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter Stationary column TruSystem 7500 U, Product Code 1730731
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction

    A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
    Category
    Medical Device
    Distribution
    Distributed nationwide