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.

226–250 of 27354

  • ModerateFDA (Devices)·Z-2538-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2669-2026·2026-07-08

    Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation

    Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.

    Product
    Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2663-2026·2026-07-08

    PowerMidline Catheter 4 Fr Dual-Lumen due to deficient manufacturing

    Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0695-2026·2026-07-08

    TERPENICOL Antifungal Cream Recalled for CGMP Deviations

    Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.

    Product
    TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2668-2026·2026-07-08

    Soft Tissue Biopsy Trays recalled due to deficient manufacturing practices

    Bard Access Systems is recalling soft tissue biopsy trays (models 4380 Economy and 4382A) due to lidocaine ampoules being manufactured under deficient manufacturing practices.

    Product
    4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2546-2026·2026-07-08

    Medline Circumcision Trays recalled due to Lidocaine quality issues

    Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.

    Product
    Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2654-2026·2026-07-08

    Medline 111 Gravity Set with Needle Free Y-Sites engineering sample recall

    BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.

    Product
    MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2545-2026·2026-07-08

    Medline L&D Continuous Epidural Tray Kits Recalled for Quality Issues

    Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2026·2026-07-08

    Fungal Fusion antifungal kit recalled for discontinued stability testing

    Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.

    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1135-2026·2026-07-08

    Dietary Supplement Vista MAX Recalled for Undeclared Yellow #5 Allergen

    Vista MAX dietary supplement contains undeclared Yellow #5 dye. Consumers allergic to or sensitive to Yellow #5 should not consume the product.

    Product
    Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2542-2026·2026-07-08

    Medline Convenience Kits recalled for defective Lidocaine Ampules

    Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.

    Product
    Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2026·2026-07-08

    vite20 Antifungal Cream recalled due to stability testing deviations

    Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.

    Product
    vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2026·2026-07-08

    Revitaderm Wound Care Benzalkonium Chloride OTC Drug Recall

    Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.

    Product
    REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2026·2026-07-08

    Medline Convenience Kits recalled due to Lidocaine quality issues

    Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.

    Product
    Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2666-2026·2026-07-08

    PowerPICC Catheters recalled for deficient manufacturing practices

    Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.

    Product
    1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2667-2026·2026-07-08

    Provena Midline Catheters recalled due to deficient manufacturing practices

    Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.

    Product
    CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2539-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0714-2026·2026-07-08

    Gemcitabine Injection Recalled Due to Temperature Storage Abuse

    McKesson is recalling Gemcitabine Injection (1 g per 26.3 mL) due to temperature abuse—the product was stored at controlled room temperature instead of under refrigeration. The affected lot was distributed nationwide.

    Product
    GEMCITABINE — GEMCITABINE (GEMCITABINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2026·2026-07-08

    Medline Convenience Kits Block Tray recalled due to quality defects

    Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.

    Product
    Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2665-2026·2026-07-08

    Groshong NXT ClearVue Catheter Recalled Due to Manufacturing Deficiency

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.

    Product
    7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2658-2026·2026-07-08

    PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall

    Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.

    Product
    CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2026·2026-07-08

    Medline Ophthalmic Pack with Lidocaine Injection Kits Recalled

    Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.

    Product
    Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2026·2026-07-08

    CRE Wireguided 8-10mm 240cm Medical Device Recall Notice

    Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.

    Product
    CRE Wireguided 8-10mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1151-2026·2026-07-08

    Blue Ribbon Classics French Vanilla Ice Cream Recalled for Elevated Coliforms

    Wells Enterprises is recalling Blue Ribbon Classics French Vanilla ice cream in 1-gallon pails due to elevated coliforms. The affected product was distributed to one customer in Kenosha, Wisconsin.

    Product
    Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE MARS, IA 51031
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2656-2026·2026-07-08

    Poly Midline Catheters recalled due to manufacturing defects

    Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline cathet
    Category
    Medical Device
    Distribution
    Distributed nationwide