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.

9401–9425 of 22113

  • 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-0389-2025·2024-11-20

    Surgical Instruments Recalled for Loose Metal Flakes in Set-Up Packs

    AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and foreign body reactions.

    Product
    Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2025·2024-11-20

    Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components

    AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.

    Product
    Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
    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-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-0337-2025·2024-11-20

    IV Fluid Pouches Found to Leak During Filling

    The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.

    Product
    SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; 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-0355-2025·2024-11-20

    Medical Laboratory Kit Recalled Due to Non-Sterile Specimen Container

    Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.

    Product
    Lab Kit, SKU DYLAB1018; Component No. 503581
    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 (Food)·F-0130-2025·2024-11-20

    Home Chef Chicken Street Taco Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Chicken Street Taco meal kits due to Listeria monocytogenes contamination in the cooked chicken. Approximately 24,072 units distributed across 31 states are affected.

    Product
    Home Chef Chicken Street Taco, Net Wt. 9.93 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430435, all lot codes
    Category
    Food
    Distribution
    31 states
  • HighFDA (Food)·F-0126-2025·2024-11-20

    Del Monte Pineapple and Apple Salad Recalled for Undeclared Walnut Allergen

    Del Monte Fresh Produce is recalling Pineapple and Apple Salad due to undeclared walnuts (tree nuts). The product may pose a risk to consumers with tree nut allergies.

    Product
    Del Monte Fresh Produce, Pineapple and Apple Salad 4/6.5oz plastic container, four containers per case. Refrigerated. Lot Code 02277101, expiration date 10/10/2024 .
    Category
    Food
    Distribution
    1 state
  • 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 (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-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-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-0358-2025·2024-11-20

    Medline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers

    Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0125-2025·2024-11-20

    Westby Pepper Cheese Curds Recalled Due to E. Coli Contamination

    Westby Cooperative Creamery is recalling Westby Pepper Cheese Curds due to potential E. coli contamination. The affected 12-ounce packages with expiration date 11-26-24 were distributed in Wisconsin.

    Product
    Westby Pepper Cheese Curds, 12 oz. (340g) UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667.
    Category
    Food
    Distribution
    1 state
  • 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-0343-2025·2024-11-20

    Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.

    Product
    Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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-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-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-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-0347-2025·2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    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
  • HighCPSC·25040·2024-11-14

    Petidoux Children's Pajamas Recalled for Burn Hazard from Flammability Violation

    Petidoux is recalling about 620 Celebration Girl's Summer Pajama Sets due to a violation of federal flammability regulations for children's sleepwear. The pajamas pose a risk of burn injuries to children.

    Product
    Celebration Girl's Summer Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide