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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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2126–2150 of 39824

  • HighFDA (Devices)·Z-0960-2026·2025-12-24

    Leukemia test kits recalled over inaccurate results with high white cell counts

    Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Sterile operating room scissors recalled over weak seals affecting sterility

    Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0943-2026·2025-12-24

    Respiratory specimen reagent recalled because fluidification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0942-2026·2025-12-24

    Sputum transfer reagent sets recalled because liquification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0944-2026·2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0935-2026·2025-12-24

    Ultrasound reporting software recalled over incomplete patient history information

    GE Healthcare is recalling 1,221 ViewPoint 6 systems because the Patient History tab in software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.

    Product
    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Bone fixation screws recalled over a labeling error on one lot

    Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2026·2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    Clotting time reagent recalled after lots were made with double preservative

    Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0947-2026·2025-12-24

    Malar facial implants recalled over specification deviations and missing clearance

    DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0937-2026·2025-12-24

    Spinal navigation guide recalled for naming an incompatible toolcard system

    SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0948-2026·2025-12-24

    Pectoral implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 si
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0946-2026·2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0945-2026·2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Medical Device
    Distribution
    27 states
  • CriticalFDA (Devices)·Z-0592-2026·2025-12-17

    ErgoStar CM 55 airway connectors recalled after cracks formed in the hose

    Draeger is recalling 118,850 ErgoStar CM 55 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-0593-2026·2025-12-17

    ErgoStar CM 60 airway connectors recalled after cracks formed in the hose

    Draeger is recalling 2,050 ErgoStar CM 60 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-0591-2026·2025-12-17

    Ventilator airway connectors recalled after cracks formed in the hose

    Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.

    Product
    ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0597-2026·2025-12-17

    Fluoroscopy systems recalled after shipping without the source-to-skin distance spacer

    Philips is recalling 110 Azurion R3.0 systems shipped with a FlexArm stand but without the Source-to-Skin Distance spacer needed to meet the FDA minimum 38 cm requirement.

    Product
    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0898-2026·2025-12-17

    Fabric bandages recalled over open package seals affecting product sterility

    Medline is recalling 182,526 CURAD Germ-Shield Touch-Free Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
    Category
    Medical Device
    Distribution
    1 state