The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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951–975 of 26077

  • HighCPSC·26440·2026-04-23

    Farm Animal Playsets Recalled for Detachable Fence Handles That Pose Choking Hazard

    KMUYSL Big Red Barn Farm Animal Playsets are being recalled because the fence handles can detach and pose a choking hazard for children under 3 years old. The toy violates federal small parts regulations.

    Product
    KMUYSL Big Red Barn Farm Animal Playsets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1800-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Air Bubble Risk

    B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line due to blood gases adhering to tubing under negative pressure. Approximately 1.17 million units have been recalled in this Class I FDA action.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1798-2026·2026-04-22

    B. Braun hemodialysis bloodline set recalled for air bubble accumulation risk

    B. Braun Medical Inc. is recalling 3,158,104 hemodialysis bloodline sets due to a defect that can cause air bubbles to accumulate in the arterial line during dialysis treatment. The product is distributed worldwide including the United States and Canada.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1797-2026·2026-04-22

    Omnipod 5 insulin pump pods recalled for cannula tear causing insulin leakage

    Omnipod 5 insulin pump pods from 49 lots have a manufacturing defect causing internal insulin leakage instead of delivery to patients. This risks dangerous blood sugar complications including diabetic emergencies.

    Product
    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1802-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled Due to Air Bubble Accumulation Risk

    B. Braun has recalled hemodialysis bloodlines due to potential air bubble accumulation in the arterial line. The recall affects 4,848 units distributed nationwide and in Canada.

    Product
    B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1801-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Accumulation

    B. Braun is recalling hemodialysis bloodlines (Model SL-2000M2095L) due to potential air bubble accumulation in the arterial line under negative pressure. Approximately 328,640 units distributed worldwide are affected.

    Product
    B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1803-2026·2026-04-22

    B Braun Hemodialysis Bloodlines Recalled for Air Bubble Accumulation

    B Braun is recalling hemodialysis bloodlines (Model B3-4630M4705, 4,884 units) due to potential air bubble accumulation in the arterial line. Units manufactured since August 5, 2025 are affected and were distributed in the US and Canada.

    Product
    B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1799-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Risk

    B. Braun Medical is recalling hemodialysis bloodline sets due to potential air bubble accumulation in the arterial line. This Class I recall affects model SL-2010M2096 manufactured since May 25, 2025, distributed worldwide.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0455-2026·2026-04-22

    SLMD Benzoyl Peroxide Acne Lotion recalled for benzene contamination

    SLMD Benzoyl Peroxide Acne Lotion 2.5% is being recalled due to benzene contamination. The affected lots are 2691700 and 2691800, distributed nationwide.

    Product
    SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2026·2026-04-22

    Injectable Sodium Chloride Ampules Recalled Over Sterility Assurance Concerns

    Spectra Medical Devices is recalling 7,120,750 ampules of 0.9% Sodium Chloride Injection, USP, nationwide due to lack of sterility assurance. The product is used for intravenous, intramuscular, and subcutaneous injection.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0458-2026·2026-04-22

    Caring Mill Menthol Cough Drops Recalled Following Manufacturing Inspection

    Caring Mill Cough Drops (Menthol) distributed nationwide are being recalled following observations noted during an FDA manufacturing facility inspection on August 15, 2025. The affected product has lot number 20241030 and expiration date October 30, 2026.

    Product
    CARING MILL COUGH DROPS CHERRY — CARING MILL COUGH DROPS CHERRY (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    FDA Recalls Cinacalcet Tablets for N-Nitroso Impurity Exceeding Limits

    Cipla USA is recalling Cinacalcet Hydrochloride tablets nationwide due to N-Nitroso Cinacalcet impurity exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2026·2026-04-22

    Bupivacaine Hydrochloride Injection Recalled for Lack of Sterility Assurance

    Bupivacaine Hydrochloride injectable anesthetic is being recalled due to lack of assurance of sterility. Approximately 3.26 million ampules distributed nationwide are affected.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0529-2026·2026-04-22

    Lidocaine Hydrochloride Injection Recalled for Sterility Assurance Issues

    Huons Co., Ltd. is recalling Lidocaine Hydrochloride injection (1% 50mg/5mL) distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0453-2026·2026-04-22

    HydroPeptide Clear Alliance Serum recalled nationwide for benzene contamination

    HydroPeptide Clear Alliance Serum containing 2.5% benzoyl peroxide is recalled nationwide due to benzene contamination. Consumers with affected products should stop use immediately.

    Product
    HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2026·2026-04-22

    Lidocaine Hydrochloride Injection Recalled Nationwide for Sterility Assurance Issues

    Lidocaine Hydrochloride injection vials are being recalled nationwide because manufacturers cannot guarantee the product's sterility. All lots within expiration are affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0465-2026·2026-04-22

    Quality Choice Honey Lemon Cough Drops Recalled Due to Manufacturing Quality Concerns

    Quality Choice Honey Lemon cough drops are being recalled due to manufacturing quality issues identified during an FDA inspection. No illnesses or injuries have been reported.

    Product
    QUALITY CHOICE — QUALITY CHOICE (COUGH DROPS HONEY LEMON SUGAR FREE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2026·2026-04-22

    React Health PHOENIX 5L Oxygen Concentrator Recalled for Quality Defects

    3B Medical is recalling two units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet internal quality specifications and were inadvertently distributed. The FDA is overseeing the recall.

    Product
    React Health PHOENIX 5L Oxygen Concentrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2026·2026-04-22

    Arjo Tenor patient lifts recalled for actuator mechanical strength failure

    The FDA recalled 119 Arjo Tenor patient lifts because internal actuator components may fail to hold patients safely, risking sudden uncontrolled descent of the lifting arm.

    Product
    Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2026·2026-04-22

    Medical device culture medium reports incorrect antifungal test results

    Yeastone Broth culture medium may report incorrect antifungal susceptibility results during quality control testing. This could delay treatment response or necessitate switching antifungal agents.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2026·2026-04-22

    Gentuity HF-OCT Imaging System May Display Repeated Frames During Pullback

    Gentuity HF-OCT imaging systems with certain software versions may display repeated frames during pullback procedures, potentially affecting measurement accuracy. The issue affects 184 units distributed in the US and internationally.

    Product
    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2026·2026-04-22

    CELLEX Photopheresis Kit Centrifuge Bowl May Dislodge and Break

    THERAKOS CELLEX Photopheresis Systems are recalled due to difficulty installing the centrifuge bowl. Improper installation may cause the bowl to dislodge and break, delaying patient treatment and causing blood loss.

    Product
    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2026·2026-04-22

    Philips AneurysmFlow medical device software recalled for unreliable metric

    Philips AneurysmFlow software is recalled because the Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably indicate aneurysm treatment success, yet physicians are relying on it for clinical decisions.

    Product
    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2026·2026-04-22

    Elegance Anterior Cervical Plate recalled due to manufacturing burr defect

    Clariance-SAS is recalling Elegance Anterior Cervical Plates due to a quality issue involving the presence of burr on the finished product. The defect affects 511 units distributed across California, Illinois, New York, and Texas.

    Product
    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" So
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2026·2026-04-22

    Cytal Wound Matrix Recalled for Out-of-Specification Endotoxin Levels

    Integra LifeSciences is recalling Cytal Wound Matrix 2-Layer 5x5 cm due to increased endotoxin levels that exceed specifications. The recall affects 148 units distributed nationwide across 31 states.

    Product
    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
    Category
    Medical Device
    Distribution
    Distributed nationwide