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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3901–3925 of 27346

  • HighFDA (Devices)·Z-0434-2025·2024-11-20

    Surgical instrument kits recalled for loose metal flakes

    AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.

    Product
    Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2025·2024-11-20

    IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall

    The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.

    Product
    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2025·2024-11-20

    Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes

    AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.

    Product
    Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2025·2024-11-20

    Surgical instrument kits recalled due to loose metal flakes

    AVID Medical is recalling Halyard Upper Extremity Pack surgical kits because sponge forceps and towel clamps may shed small metal flakes. These flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2025·2024-11-20

    IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim

    Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.

    Product
    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2025·2024-11-20

    IV Bag Containers Recalled for Leaking During Filling Process

    The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.

    Product
    CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2025·2024-11-20

    MEERA CL operating table may stop unexpectedly during surgical procedures

    The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2025·2024-11-20

    Halyard MINOR PACK Medical Kits Recalled for Loose Metal Fragments in Instruments

    AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, potentially causing local or foreign body reactions.

    Product
    Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2025·2024-11-20

    Surgical forceps and clamps recall due to potential loose metal flakes

    AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.

    Product
    Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.

    Product
    Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2025·2024-11-20

    MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur

    The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2025·2024-11-20

    Halyard GYN TRAY surgical kits recalled for loose metal flakes

    AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2025·2024-11-20

    Surgical forceps and clamps recalled due to detachable metal flakes

    AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.

    Product
    Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.

    Product
    Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2025·2024-11-20

    Halyard ENDOVASCULAR surgical kits recalled for loose metal flakes

    Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.

    Product
    Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0392-2025·2024-11-20

    Halyard cardiac surgical kit recalled for loose metal flakes risk

    AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2025·2024-11-20

    Halyard SPINE Kit recalled for loose metal flakes in surgical instruments

    AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2025·2024-11-20

    Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes

    AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.

    Product
    Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2025·2024-11-20

    Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat

    Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.

    Product
    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2025·2024-11-20

    Medical Surgical Kit Recalled for Potential Loose Metal Flake Hazard

    AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.

    Product
    Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0326-2025·2024-11-13

    Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring

    Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.

    Product
    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0325-2025·2024-11-13

    Cardiac stress testing system may assign duplicate exam identifiers to patients

    Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.

    Product
    Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0323-2025·2024-11-13

    Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

    Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

    Product
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0309-2025·2024-11-13

    DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled

    DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.

    Product
    DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
    Category
    Medical Device
    Distribution
    Distributed nationwide