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.

8526–8550 of 88183

  • 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 (Devices)·Z-1390-2025·2025-04-02

    Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk

    Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0301-2025·2025-04-02

    SinuCleanse Neti Pot Nasal Wash System Recalled for Bacterial Contamination

    Ascent Consumer Products Inc. is recalling SinuCleanse Soft Tip Neti Pot Nasal Wash System due to bacterial contamination with Staphylococcus aureus. Consumers should stop using this product immediately.

    Product
    SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
    1 state
  • 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
    1 state
  • 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
  • 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 (Devices)·Z-1466-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk

    The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2025·2025-04-02

    Baxter Operating Table Column Software Issue Limits Emergency Mode Function

    Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.

    Product
    Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0296-2025·2025-04-02

    Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure

    QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 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…
    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-1428-2025·2025-04-02

    Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect

    Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
    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-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-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-1436-2025·2025-04-02

    Medline Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2025·2025-04-02

    CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues

    St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.

    Product
    CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary…
    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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2025·2025-04-02

    Baxter TruSystem 7500 Stationary Column Recalled for Software Emergency Mode Defect

    Baxter Healthcare is recalling 462 units of the TruSystem 7500 Stationary column 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, Product Code 1717020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2025·2025-04-02

    Contact lenses for astigmatism recalled due to incorrect cylinder power

    CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.

    Product
    Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1440-2025·2025-04-02

    Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk

    Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.

    Product
    Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
    Category
    Medical Device
    Distribution
    Distributed nationwide