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.

6451–6475 of 52960

  • HighFDA (Devices)·Z-0360-2025·2024-11-20

    Urine kit specimen containers recalled for non-sterile condition

    Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.

    Product
    URINE KIT, SKU DYKM1845; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0131-2025·2024-11-20

    Home Chef Asian Style Chicken Stir Fry Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Asian Style Chicken Stir Fry due to potential contamination with Listeria monocytogenes. The recall affects 31,424 consumer units distributed across the United States.

    Product
    Home Chef Asian Style Chicken Stir Fry, Net Wt. 13 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430852, all lot codes
    Category
    Food
    Distribution
    31 states
  • 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-0356-2025·2024-11-20

    UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling

    MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.

    Product
    UA KIT, SKU DYKM1690A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2025·2024-11-20

    Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

    Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

    Product
    Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
    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
  • HighFDA (Devices)·Z-0447-2025·2024-11-20

    Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site

    AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.

    Product
    Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
    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-0435-2025·2024-11-20

    Halyard C Section Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

    Product
    Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2025·2024-11-20

    IV Fluid Container Bags Recalled for Potential Leaks During Filling

    The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.

    Product
    SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; 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 (Drugs)·D-0042-2025·2024-11-20

    Trinity Gold Nutrition Capsules Recalled for Undeclared Drug Ingredients

    Trinity Gold Nutrition capsules (Lot IN-030, expiring November 2027) have been recalled for containing three undeclared pharmaceutical ingredients: acetaminophen, diclofenac, and phenylbutazone. These unapproved drugs could cause health risks through medication interactions and adverse effects.

    Product
    Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2025·2024-11-20

    Surgical instrument kits recalled for potential loose metal flake hazard

    Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.

    Product
    Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V876000·2024-11-20

    Oliver travel trailer water heater burner brackets may loosen and misdirect flame

    Oliver Travel Trailers is recalling certain 2016-2024 Elite I and Elite II trailers because the Truma water heater burner bracket may loosen, misdirecting the flame.

    Product
    OLIVER TRAVEL TRAILERS — OLIVER TRAVEL TRAILERS LEGACY ELITE, LEGACY ELITE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2025·2024-11-20

    Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally

    Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
    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-0386-2025·2024-11-20

    ENT surgical kit recalled for potentially detachable metal flakes in forceps

    AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.

    Product
    Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
    Category
    Medical Device
    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-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
  • 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-0450-2025·2024-11-20

    Surgical kits recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
    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-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-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-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