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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3101–3125 of 39948

  • HighFDA (Devices)·Z-2635-2025·2025-10-01

    Allura CV20 systems recalled over internal component deterioration disabling motorized movement

    Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.

    Product
    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2025·2025-10-01

    Big Bore CT systems recalled because patient table may descend unexpectedly

    Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2025·2025-10-01

    Intravenous solution sets recalled after customer reports of tubing separation

    Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.

    Product
    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2025·2025-10-01

    Brilliance iCT systems recalled over ball screw misalignment dropping the couch

    Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2025·2025-10-01

    Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration

    Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.

    Product
    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2025·2025-10-01

    Philips Brilliance iCT SP CT Systems Patient Support Table Descent

    Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2025·2025-10-01

    MyDay toric contact lenses recalled after one lot used invalid sterilization

    MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.

    Product
    MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2025·2025-10-01

    Insulin pump app recalled over defect in right-to-left language settings

    The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.

    Product
    t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2603-2025·2025-10-01

    Ingenuity CT Brazil family recalled over patient table descending to lowermost position

    Philips Ingenuity CT Family Brazil systems, model 728325, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 3 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2631-2025·2025-10-01

    Allura Xper FD20/20 OR Table recalled over deteriorating internal system components

    Philips Allura Xper FD20/20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 3 units are affected.

    Product
    Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2605-2025·2025-10-01

    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device recalled

    Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.

    Product
    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2025·2025-10-01

    Surgical light systems recalled over powder coating stress lines and chipping

    Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.

    Product
    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration

    Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2025·2025-10-01

    Soft tissue anchors recalled after cartons packed with wrong device size

    Zimmer Biomet is recalling JuggerKnot Mini Soft Anchors after outer cartons labeled for the 1.0mm Mini product were found to contain 1.4mm Short devices instead.

    Product
    Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2025·2025-10-01

    Philips Allura Xper FD10/10 X-Ray System Motorized Movement Failure Recall

    Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements remain functional.

    Product
    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2025·2025-10-01

    FilmArray NGDS Warrior Panel diagnostic test system recall notice

    Biofire Defense is recalling the FilmArray NGDS Warrior Panel due to increased risk of internal control failures when testing positive blood cultures, which may delay results and require additional diagnostic evaluation.

    Product
    FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2025·2025-10-01

    Extractor Pro RX Retrieval Balloon Catheter incorrectly labeled

    Boston Scientific Corporation is recalling Extractor Pro RX Retrieval Balloon Catheters because the label incorrectly indicates the position of the skive hole relative to the balloon.

    Product
    Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2539-2025·2025-09-24

    SmartDrive MX2-3DCK dials recalled over faulty connection to wheelchair motor

    SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Devices)·Z-2538-2025·2025-09-24

    Wheelchair power assist speed dials recalled over potential loss of control

    SmartDrive MX2+ SpeedControl Dials are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. The FDA classified the action as Class I. 25,389 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Devices)·Z-2540-2025·2025-09-24

    SmartDrive speed control dials recalled over faulty motor electrical connection

    SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCMC, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 8,413 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Devices)·Z-2483-2025·2025-09-24

    Blood and fluid warming sets recalled to clarify flow rates and temperatures

    3M Ranger Blood/Fluid Warming High Flow Sets are the subject of a field action to clarify flow rates, inlet fluid temperatures and the location of the outlet temperature. The FDA classified it as Class I.

    Product
    3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2025·2025-09-24

    Radiation planning software recalled over image errors in three patient orientations

    Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.

    Product
    Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2025·2025-09-24

    Lubri-Sil Foley trays recalled over inserts describing the wrong catheter material

    SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.

    Product
    SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
    Category
    Medical Device
    Distribution
    Distributed nationwide