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.

826–850 of 88106

  • HighFDA (Food)·H-1307-2026·2026-09-09

    Prince Bakery Recalls Pan De Manteca for Undeclared Milk Allergen

    Prince Bakery Inc is recalling 150 units of Pan De Manteca in New York because milk is not declared in the Contains statement.

    Product
    Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3075-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects

    Medline is recalling specific lots of convenience kits containing BD ChloraPrep applicators due to potential packaging seal defects that could allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3068-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects

    Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators because packaging seals may be open or incomplete, posing a risk of infection.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3043-2026·2026-09-09

    Philips CT Systems Recalled for Unintended Radiation Performance Issues

    Philips is recalling Brilliance CT 64 systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3052-2026·2026-09-09

    Medline Colorectal Convenience Kits Recalled for Potential Sterility Breach

    Medline is recalling 176 colorectal convenience kits due to potential packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3045-2026·2026-09-09

    AVID Medical Recalls Neurological Sponges Due to Endotoxin Variability

    AVID Medical, Inc. is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.

    Product
    1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3041-2026·2026-09-09

    Philips Recalls IQon Spectral CT Systems Due to Radiation Issue

    Philips is recalling IQon Spectral CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0815-2026·2026-09-09

    Baxter Recalls Clindamycin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Clindamycin Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3079-2026·2026-09-09

    Medline Ortho Aspiration Kits Recalled for Potential Contamination

    Medline is recalling Ortho Aspiration Kits containing BD ChloraPrep applicators due to packaging seal defects that may allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3051-2026·2026-09-09

    Medline IVS Blood Culture Kits Recalled for Sterility Breach

    Medline is recalling 17,750 IVS Blood Culture Kits nationwide due to potential packaging defects that may compromise sterility.

    Product
    Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2026·2026-09-09

    Baxter Novum IQ Syringe Pump Software Issue Recall

    Baxter Healthcare is recalling 14,601 Novum IQ Syringe Pumps due to a software issue that may occur during multi-syringe infusions.

    Product
    Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0813-2026·2026-09-09

    Baxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of CARDENE IV (Nicardipine Hydrochloride) injection due to CGMP deviations. The recall covers products distributed in the US, Puerto Rico, and Chile.

    Product
    CARDENE IV — CARDENE IV (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2026·2026-09-09

    Baxter Recalls Vasopressin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE — VASOPRESSIN IN 0.9% SODIUM CHLORIDE (VASOPRESSIN IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3083-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alert notifications, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3064-2026·2026-09-09

    Johnson & Johnson Recalls HEALON Viscoelastic Products Due to Surgical Instructions

    Johnson & Johnson is recalling HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products because surgical instructions may not adequately warn against forcing the cannula, which could cause eye injury.

    Product
    HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1306-2026·2026-09-09

    Prince Bakery Recalls Sesame French Bread for Undeclared Allergen

    Prince Bakery Inc is recalling 150 units of Prince Sesame French Bread in New York because sesame is not declared in the ingredient statement.

    Product
    Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g); INGREDIENTS: ENRICHED BLEACHED FLOUR, (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3055-2026·2026-09-09

    Medline Arterial Line Insertion Kits Recalled for Sterility Breach

    Medline is recalling 1,840 Arterial Line Insertion Kits due to potential packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0818-2026·2026-09-09

    Baxter Recalls Clindamycin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Clindamycin Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3042-2026·2026-09-09

    Philips CT Systems Recalled for Unintended Radiation Performance Issues

    Philips is recalling specific CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3091-2026·2026-09-09

    Fresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to complaints of blue-green discoloration in the product.

    Product
    GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3078-2026·2026-09-09

    Medline Recalls Cataract Preop Kits with Potentially Contaminated Applicators

    Medline is recalling specific lots of Cataract Preop Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3074-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects

    Medline is recalling specific lots of convenience kits containing BD ChloraPrep applicators due to potential packaging seal defects that could allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3081-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3044-2026·2026-09-09

    AVID Medical Recalls Halyard Kits Due to Endotoxin Variability

    AVID Medical, Inc. is recalling 11,763 Halyard medical convenience kits due to potential unexpected variability in endotoxin levels.

    Product
    Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3054-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential Sterility Breach

    Medline is recalling 434,595 convenience kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY…
    Category
    Medical Device
    Distribution
    Distributed nationwide