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.

751–775 of 88106

  • ModerateFDA (Drugs)·D-0841-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product was distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0869-2026·2026-09-16

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide and fibers.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-1330-2026·2026-09-16

    FDA Recalls Gluten-Free Veggie Chips for Undeclared Wheat

    Exotique Foods Canada is recalling Momchipz Gluten Free Veggie Chips due to undeclared wheat. The product was sold in the U.S. and poses a risk to individuals with wheat allergies.

    Product
    Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imported for Exotique Foods, Inc. Toronto, ON - Canada.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-3107-2026·2026-09-16

    Medical Action Industries Recalls Single Shot Epidural Kits Due to Sterility Concerns

    Medical Action Industries is recalling Single Shot Epidural kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-0865-2026·2026-09-16

    American Regent Recalls Epinephrine Vials Due to Particulate Matter

    American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection due to the presence of particulate matter and broken vials.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1341-2026·2026-09-16

    International Sprout Holdings Recalls Alfalfa for Potential E. coli and Salmonella

    International Sprout Holdings is recalling 50 lb. bags of alfalfa due to potential E. coli and Salmonella contamination. The product was distributed to wholesale consignees in 16 states, Puerto Rico, and several international locations.

    Product
    Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Devices)·Z-3133-2026·2026-09-16

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate due to high endotoxin levels. The product is used in hemodialysis.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3106-2026·2026-09-16

    Medical Action Industries Recalls Epidural Kits Due to Compromised Sterility

    Medical Action Industries is recalling Epidural/Pain TQC kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-3136-2026·2026-09-16

    Nipro Citric Complete Liquid Citric Acid Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling Citric Complete Liquid Citric Acid Concentrate due to high endotoxin levels. The product was distributed in the US and internationally.

    Product
    Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0850-2026·2026-09-16

    Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter

    Baxter Healthcare is recalling 606 bags of Dextrose Injection, USP, 70% due to the presence of stainless steel particles in the solution.

    Product
    Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1331-2026·2026-09-16

    Crown Farms Dried Suri Cut Recalled for Improper Evisceration

    Euro Foods Group USA NJ Inc is recalling Crown Farms Dried Suri Cut because the dried fish was not properly eviscerated prior to drying.

    Product
    Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-3090-2026·2026-09-16

    Given Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure

    Given Imaging is recalling Bravo CF capsule delivery devices because they may fail to attach to the esophagus or detach from the device, posing risks of aspiration and perforation.

    Product
    Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3110-2026·2026-09-16

    Lutronic DermaV Laser System Recalled for Potential Patient Burn Risk

    Lutronic Corporation is recalling 1,065 DermaV Laser Systems because using higher fluences at 1064nm with current cryogen parameters may cause sparks or loud noise, potentially resulting in patient burns.

    Product
    Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3118-2026·2026-09-16

    C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination

    C.R. Bard is recalling SureStep Foley and Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3109-2026·2026-09-16

    AVID Medical Recalls Halyard IV Start Kits Due to Seal Defects

    AVID Medical is recalling 98 Halyard IV Start Kits because wrinkles in the paper lidding may breach the seal, compromising sterility assurance.

    Product
    Halyard IV Start Kit Non-Sterile REF: KRIV26-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3112-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical is recalling specific lots of Getinge PVC Thoracic Catheters because one lot failed bacterial endotoxin testing.

    Product
    Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3117-2026·2026-09-16

    C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination

    C.R. Bard is recalling SureStep Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3114-2026·2026-09-16

    C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination

    C.R. Bard is recalling 12,463 Foley and intermittent catheter trays because complaints indicated contamination on the surface of the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3119-2026·2026-09-16

    C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination

    C.R. Bard Inc. is recalling SureStep Foley and Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.

    Product
    Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3120-2026·2026-09-16

    HeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail

    HeartSine Technologies is recalling SAM 350P, 360P, and 450P defibrillators due to a damaged membrane tail that causes intermittent faults.

    Product
    HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because bacterial endotoxin testing results were out of specification.

    Product
    Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1335-2026·2026-09-16

    Prolon Everyday Apulian Almond & Cocoa Spread Recalled for Undeclared Tree Nuts

    L-Nutra Inc is recalling Prolon Everyday Apulian Almond & Cocoa Spread because it contains undeclared hazelnut, cashew, and pistachio.

    Product
    Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
    Category
    Food
    Distribution
    Distributed nationwide