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.

6676–6700 of 26961

  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2025·2025-04-02

    Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns

    American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.

    Product
    Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • 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 10
    Category
    Drug
    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-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-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-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-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 (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 (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 (Devices)·Z-1445-2025·2025-04-02

    Medline Laceration Tray Procedure Kits Recalled for Syringe Defects

    Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential risk to patient health.

    Product
    Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1462-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

    Product
    Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2025·2025-04-02

    Cardiac catheterization kit recalled due to sterility concerns

    American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.

    Product
    Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1444-2025·2025-04-02

    Medline surgical procedure kits recalled for syringe leaks and breakage

    Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
    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-1438-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
    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) AN
    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-1454-2025·2025-04-02

    Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure

    Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.

    Product
    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2025·2025-04-02

    Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance

    QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 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-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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) EN
    Category
    Medical Device
    Distribution
    Distributed nationwide