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.

10301–10325 of 88183

  • HighFDA (Drugs)·D-0049-2025·2024-11-27

    Guaifenesin-Dextromethorphan Cough Syrup Recalled for Failed Impurity Specifications

    Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.

    Product
    Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2025·2024-11-27

    Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy

    Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.

    Product
    Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure

    Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2025·2024-11-27

    Posi-Stop Injection Needles Recalled Due to Manufacturing Debris Blocking Injection Flow

    Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0059-2025·2024-11-27

    Calcium Antacid (Calcium Carbonate) Recall Due to Blister Packaging Separation

    Safecor Health recalls 791 boxes of Calcium Carbonate chewable tablets (Lot 24A0073) due to cGMP deviations where blister card-foils separated from blister cavities.

    Product
    CALCIUM ANTACID — CALCIUM ANTACID (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0056-2025·2024-11-27

    Vitamin D3 Dietary Supplement Recalled for Packaging Defect

    Safecor Health is recalling specific lots of Vitamin D3 25 mcg tablets due to a manufacturing defect where blister card-foils may separate from the blister cavity. No illnesses or injuries have been reported.

    Product
    Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0058-2025·2024-11-27

    Aspirin 81 mg chewable tablets recalled due to packaging defect

    Safecor Health, LLC is recalling 1,470 boxes of Aspirin 81 mg chewable tablets nationwide due to a manufacturing defect where blister card-foils are separating from the blister cavity.

    Product
    ASPIRIN — ASPIRIN (ASPIRIN 81 MG)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0048-2025·2024-11-27

    Triamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance

    Padagis is recalling 10,872 jars of Triamcinolone Acetonide Cream USP 0.025% nationwide because some jars contain subpotent or superpotent active ingredient levels. The defect was discovered during long-term stability testing.

    Product
    Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0139-2025·2024-11-27

    Dietary Supplement Recalled: Douglas Labs Stress-B-Plus Due to Niacin Form Mismatch

    Nestle Health Science is recalling Douglas Labs Stress-B-Plus Dietary Supplement due to incorrect formulation. The product contains Niacin as Nicotinic acid but the label states Niacinamide.

    Product
    Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944 and 50344396. Expiration Date 04/11/2026
    Category
    Drug
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0498-2025·2024-11-27

    Olympus Gastrointestinal Videoscope Drying Instructions Clarified

    Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.

    Product
    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2025·2024-11-27

    Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues

    NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.

    Product
    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0057-2025·2024-11-27

    Vitamin B1 Supplement Recalled for Blister Packaging Defect

    Safecor Health is recalling certain Vitamin B1 supplements due to manufacturing defects where blister card-foils are separating from the blister cavity.

    Product
    Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0303-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.

    Product
    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0310-2025·2024-11-20

    Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors

    Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.

    Product
    Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0135-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling 42 cases of raw yellow onions in 5-lb bags distributed to food service facilities across six states due to potential E. coli O157:H7 contamination.

    Product
    raw, yellow onions (whole unpeeled), intended for food service, repacked into in 5-lb plastic bags
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0304-2025·2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0327-2025·2024-11-20

    Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure

    Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.

    Product
    Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0296-2025·2024-11-20

    Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure

    Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.

    Product
    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0297-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0137-2025·2024-11-20

    Yellow Onion Products Recalled for E. Coli O157:H7 Contamination

    IMPERIALFRESH processed yellow onions are being recalled due to potential E. coli O157:H7 contamination. Products were distributed in Colorado and produced October 8-22, 2024.

    Product
    Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147 4/5LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 1/4 All lot codes; 259369 1…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0138-2025·2024-11-20

    Processed Fajita Peppers Recalled for Potential E. coli O157:H7 Contamination

    ImperialFresh processed fajita peppers made by FreshPoint Denver, Incorporated have been recalled due to potential E. coli O157:H7 contamination. Seven cases distributed in Colorado are affected.

    Product
    154784 1 / 5LB IMPERIALFRESH PROC FAJITA GRN PEPRED PEP W All lot codes
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide