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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

2201–2225 of 27375

  • CriticalFDA (Devices)·Z-2484-2025·2025-09-17

    Aspiration biopsy needles recalled over undetected deformed atraumatic tips

    ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.

    Product
    ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2025·2025-09-17

    Urinary protein assay recalled over falsely depressed patient and calibration results

    Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2025·2025-09-17

    Knee tibial components recalled because security screws were left uncoated

    LinkSymphoKnee modular TiNbN tibial components, size 5, REF 880-100/50, are recalled because some were manufactured with two uncoated security screws. 8 units are affected.

    Product
    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2025·2025-09-17

    Hemostasis valves recalled because deformed quad rings may shed foreign bodies

    10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.

    Product
    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2025·2025-09-17

    Encore 26 inflation devices recalled over foreign material particles migrating into catheters

    Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.

    Product
    Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2548-2025·2025-09-17

    Glenoid reamer sleeves recalled over potential for reamer kicking or binding

    DJO Surgical Altivate Reverse Wedge Glenoid Reamer Sleeves are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 447 units are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2025·2025-09-17

    Shoulder glenoid tray kits recalled because the reamer may kick or bind

    DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2025·2025-09-17

    Angled punch awls recalled following failure of fusion system instruments

    TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.

    Product
    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2025·2025-09-17

    ENT convenience packs recalled over open header bag seals compromising sterility

    Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.

    Product
    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2025·2025-09-17

    Dipstick strep A tests recalled over potential for false positive results

    QuickVue Dipstick Strep A Tests are recalled because the test has the potential for false positive results. 22,470 units are affected.

    Product
    QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2025·2025-09-17

    Encore Advantage kits recalled over particles migrating from the inflation device

    Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.

    Product
    Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2535-2025·2025-09-17

    NephroMax kits recalled because inflation device particles may enter balloon catheters

    Boston Scientific NephroMax Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 458 units are affected.

    Product
    Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2547-2025·2025-09-17

    Glenoid reamer boss drills recalled because the reamer may kick or bind

    DJO Surgical Altivate Reverse Wedge Glenoid Reamer Boss Drills, 6.5 mm, are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 907 units are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2025·2025-09-17

    Raman spectrometers recalled over two newly identified laser safety failure modes

    Wasatch Photonics Raman spectrometers are recalled after two potential laser safety failure modes were identified in the product design. The firm states the modes have never been found to occur. 192 units are affected.

    Product
    Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2554-2025·2025-09-17

    Spinal inserters recalled over difficulty disengaging implants and incorrect UDI marking

    Reef TA Inserters, part number TA2-001003, are recalled because they may contribute to difficulty disengaging the implant or improper implant positioning, and may carry incorrect UDI-DI marking. 74 units are affected.

    Product
    Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2025·2025-09-17

    Angled screwdrivers recalled after fusion system instruments failed in the field

    TiBrid SA Angled Screwdrivers in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.

    Product
    TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2025·2025-09-17

    Cardiovascular software recalled because it may display outdated information

    IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.

    Product
    IntelliSpace Cardiovascular, Software 8.0.0.4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2025·2025-09-17

    Introducer sheath systems recalled over pouch labels showing the wrong size

    Fortress Introducer Sheath Systems, 6F straight 45 cm, lot 800989, are recalled because units may carry a pouch label listing the reference number and UDI of the 4F version. 2,500 units are affected.

    Product
    Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2025·2025-09-17

    Glenoid reamer heads recalled because they may kick or bind during use

    DJO Surgical Altivate Reverse Wedge Glenoid Reamer Heads are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 927 units are affected.

    Product
    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2025·2025-09-17

    CELSITE BabyPort sets recalled over potential vessel damage or tearing

    CELSITE BabyPort Set PUR 4.5F IV, catalog 5433742, lot 37041185, is recalled because of the potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. 58 units are affected.

    Product
    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2536-2025·2025-09-17

    UroMax Ultra kits recalled over particles migrating from the inflation device

    Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.

    Product
    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2455-2025·2025-09-10

    Multi Joystick wheelchair controls recalled over unintended movement at power-up

    Multi Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.

    Product
    Multi Joystick R-net. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2428-2025·2025-09-10

    Transseptal access systems recalled over higher air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. 340,185 units are affected.

    Product
    WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2433-2025·2025-09-10

    TruSeal ANT access systems recalled over air embolism risk without controlled ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System ANT after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states