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.

9351–9375 of 22113

  • HighFDA (Devices)·Z-0455-2025·2024-11-20

    Halyard ANGIO PACK surgical kits recalled for loose metal fragments

    AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.

    Product
    Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2025·2024-11-20

    Halyard TOTAL KNEE Medical Convenience Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2025·2024-11-20

    Medline Iris Scissors Recalled for Potential Sterility Barrier Compromise

    Medline is recalling 69,611 single-use iris scissors because the tip protector may fall off during packaging, compromising the sterile barrier. Affected units were distributed nationwide to 20 states.

    Product
    Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
    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-0383-2025·2024-11-20

    Medical Drainage Pack Components Recalled for Potential Metal Fragments

    AVID Medical is recalling the Halyard IR Abcess Drainage Pack due to sponge forceps and towel clamps that may have loose metal flakes. Metal flakes could detach and enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2025·2024-11-20

    Halyard Knee Arthroscopy Packs recalled due to loose metal flakes

    AVID Medical recalls Halyard Knee Arthroscopy Packs due to loose metal flakes that could detach from forceps and clamps. Metal fragments may enter the surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2025·2024-11-20

    Urine Collection Kit Specimen Containers Recalled Due to Sterility Defect

    Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.

    Product
    URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2025·2024-11-20

    Clean Catch Kit specimen containers recalled for sterility labeling failure

    Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.

    Product
    Clean Catch Kit, SKU DYKM1833A; Component No. 503581
    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-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-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
  • HighFDA (Devices)·Z-0338-2025·2024-11-20

    IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.

    Product
    SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; 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-0413-2025·2024-11-20

    Halyard Pacemaker Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard Pacemaker Pack surgical kits because sponge forceps and towel clamps contain loose metal flakes that could detach and enter patient surgical sites.

    Product
    Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
    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-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-0446-2025·2024-11-20

    Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
    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-0359-2025·2024-11-20

    Medline urine collection kits recalled for non-sterile specimen containers

    Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2025·2024-11-20

    Medical Convenience Kits Recalled for Detachable Metal Flakes in Surgical Instruments

    AVID Medical is recalling Halyard Shoulder Pack medical convenience kits because the sponge forceps and towel clamps contain loose metal flakes that could detach and enter a patient's surgical site during use, potentially causing foreign body reactions.

    Product
    Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2025·2024-11-20

    Medical surgical kits recalled due to loose metal flakes

    AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.

    Product
    Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2025·2024-11-20

    Halyard Laparotomy GYN Packs recalled due to loose metal flakes

    AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.

    Product
    Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
    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-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-0393-2025·2024-11-20

    Halyard Anterior Hip Pack surgical kits recalled due to loose metal flakes

    AVID Medical is recalling Halyard Anterior Hip Pack surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach, enter a patient's surgical site undetected, and cause local or foreign body reactions.

    Product
    Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2025·2024-11-20

    Halyard Angio Tray surgical kits recalled for loose metal flakes

    AVID Medical recalls Halyard ANGIO TRAY (Model VAPX021-05) surgical kits due to potential loose metal flakes on forceps and clamps that could enter surgical sites and cause local or foreign body reactions.

    Product
    Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05
    Category
    Medical Device
    Distribution
    Distributed nationwide