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.

3126–3150 of 88106

  • HighFDA (Devices)·Z-1794-2026·2026-04-15

    MicroScan multidrug resistance test panels recalled over incorrect processing

    MicroScan Neg Multidrug Resistant MIC 1 panels are being recalled because of a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. Three boxes are affected.

    Product
    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0433-2026·2026-04-15

    Fresenius sodium chloride 1,000 mL dialysis-supplied bags recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by Fresenius Medical Care RTG, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2026·2026-04-15

    Cipla lanreotide syringes with safety needle recalled over sterility assurance

    Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes supplied with a safety needle, citing lack of assurance of sterility. 54,583 syringes are affected.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2026·2026-04-15

    Multi-parameter command modules may produce inaccurate cardiac output readings

    A circuit board issue in Multi-parameter Command Module model 91496 can start cardiac output measurement early in Auto mode, producing errors and inaccurate readings. 1,790 units are affected.

    Product
    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2026·2026-04-15

    Fresenius Kabi 100 mL sodium chloride freeflex bags recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 100 mL freeflex bags under its own label, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0427-2026·2026-04-15

    Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 250 mL freeflex bags under its own label, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2026·2026-04-15

    Molded Products Luer cap sets recalled after threaded sleeve detachment complaint

    Molded Products is recalling the MPC-130 See Luer Cap Set following a confirmed complaint that the threaded sleeve was not engaged and became detached. 26,900 units are affected.

    Product
    See Luer Cap Set, MPC-130, set, administration, intravascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0430-2026·2026-04-15

    Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2026·2026-04-15

    Cook Medical bile duct exploration sets labeled with overstated expiration dates

    Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    Product
    COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1777-2026·2026-04-15

    Cook Medical CTO-18 wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.

    Product
    COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0446-2026·2026-04-15

    Teva isotretinoin 40 mg capsules recalled as superpotent and subpotent

    Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-1788-2026·2026-04-15

    Cook Medical central venous catheter sets labeled with overstated expiration dates

    Cook Medical is recalling Spectrum Central Venous Catheter Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 5,080 units are affected.

    Product
    COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1780-2026·2026-04-15

    Blue Rhino G2-Multi tracheostomy introducer trays carry overstated expiration dates

    Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 441 units are affected.

    Product
    COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0440-2026·2026-04-15

    Fagron vancomycin 1.25 gram bags recalled over sterility and detaching port part

    Fagron is recalling Vancomycin HCl 1.25 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2026·2026-04-15

    Cook Medical Spectrum central venous catheter trays carry overstated expiration dates

    Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.

    Product
    COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1789-2026·2026-04-15

    Cook Medical Spectrum central venous trays carry overstated expiration dates

    Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.

    Product
    COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0428-2026·2026-04-15

    Fresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance

    Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 500 mL freeflex bags under its own label, citing lack of assurance of sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0442-2026·2026-04-15

    Fagron vancomycin infusion bags recalled over sterility and detaching port part

    Fagron Sterile Services is recalling Vancomycin HCl 1 gram in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2026·2026-04-15

    Cook Medical chest tube tray labeled with an overstated expiration date

    Cook Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.

    Product
    COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0441-2026·2026-04-15

    Fagron vancomycin 1.5 gram bags recalled over sterility and detaching port part

    Fagron is recalling Vancomycin HCl 1.5 grams in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.

    Product
    Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0650-2026·2026-04-15

    Zarlengo's Chocolate Chocolate Chip Gelato Recalled for Undeclared Soy Allergen

    Zarlengo Italian Ice is recalling Chocolate Chocolate Chip Gelato in multiple sizes because soy lecithin is listed in the ingredients but soy is not declared in the allergen statement, posing a risk to consumers with soy allergies.

    Product
    Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1785-2026·2026-04-15

    Cricothyrotomy catheter sets labeled with overstated expiration dates

    Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.

    Product
    Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
    Category
    Medical Device
    Distribution
    0 states