The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6526–6550 of 52962

  • HighFDA (Devices)·Z-0436-2025·2024-11-20

    AVID Medical Recalls Halyard GYN PAC Kits Due to Metal Flakes

    AVID Medical is recalling Halyard GYN PAC medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2025·2024-11-20

    IV Fluid Bags Recalled Due to Leaking During Filling

    The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.

    Product
    Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-0332-2025·2024-11-20

    IV Fluid Containers Recalled for Leakage Risk During Filling

    The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.

    Product
    CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; 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-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-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-0335-2025·2024-11-20

    IV Fluid Container Bags Recalled for Leaking Defect

    The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.

    Product
    SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; 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-0419-2025·2024-11-20

    Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments

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

    Product
    Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2025·2024-11-20

    Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk

    Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.

    Product
    Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2025·2024-11-20

    Surgical procedure kits recalled due to loose metal flakes in instruments

    AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2025·2024-11-20

    IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units

    The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.

    Product
    SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V875000·2024-11-20

    Volkswagen ID.4 rearview camera image may not display in reverse

    Volkswagen is recalling certain 2023 ID.4 vehicles because the rearview camera image may not display when the vehicle is placed in reverse, failing FMVSS 111.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2025·2024-11-20

    IV Bag Containers Recalled Due to Leaking During Filling

    The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.

    Product
    CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; 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-0416-2025·2024-11-20

    Halyard Extremity Pack Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.

    Product
    Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2025·2024-11-20

    Stryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation

    Stryker Corporation is recalling 21,490 Neptune SafeAir Smoke Evacuation Pencils due to risk of unintended activation that could cause electrical burns. The device may activate without user input or remain active after buttons are released.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation
    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-0349-2025·2024-11-20

    Surgical hip procedure kit recalled for incomplete product seals

    Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.

    Product
    CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
    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-0454-2025·2024-11-20

    Medical convenience kits recalled due to detachable metal flakes

    AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2025·2024-11-20

    Halyard PACK MINOR surgical instrument kits recalled for metal flake contamination

    AVID Medical is recalling Halyard PACK MINOR surgical kits due to loose metal flakes that may detach from forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2025·2024-11-20

    AVID Medical Recalls Halyard MINOR PDS Medical Convenience Kits

    AVID Medical, Inc. is recalling 137 Halyard MINOR PDS medical convenience kits because sponge forceps and towel clamps may release metal flakes into surgical sites.

    Product
    Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2025·2024-11-20

    AVID Medical Recalls Halyard Line Insertion Packs Due to Metal Flakes

    AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2025·2024-11-20

    AVID Medical Recalls Halyard CPT PEDS ADULT CH PACK Surgical Kits

    AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.

    Product
    Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2025·2024-11-20

    Metrix SECURE 1000 mL IV Container Recall Due to Leaking

    The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.

    Product
    SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; 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-0422-2025·2024-11-20

    Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes

    AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide