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.

28651–28675 of 50488

  • HighFDA (Devices)·Z-1974-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 Single-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2018·2018-06-06

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2018·2018-06-06

    Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2018·2018-06-06

    Liberty Snacks Natural Pistachios Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Natural Pistachios because a product in the same storage bin tested positive for Listeria monocytogenes.

    Product
    Liberty Snacks Natural PISTACHIOS Net Wt. 1 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17158-4
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1983-2018·2018-06-06

    Arrow International Recalls MAC Two-Lumen Central Venous Access Kits

    Arrow International Inc is recalling MAC Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Sutures

    Torax Medical is recalling LINX Reflux Management System implant sutures because a manufacturing defect may cause beads to separate from wire links, potentially rendering the device discontinuous.

    Product
    LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2018·2018-06-06

    Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise

    Arrow International is recalling Maximal Barrier Drapes because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00376-SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2018·2018-06-06

    Liberty Snacks Raw Almonds Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Raw Almonds due to Listeria monocytogenes detected in a product stored in the same bin.

    Product
    Liberty Snacks Raw ALMONDS Net Wt. 1.3 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17157-7
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-1980-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1568-2018·2018-06-06

    Dawn's Foods Deluxe Potato Salad Recalled for Listeria Risk

    Morski Brands Inc. is recalling Dawn's Foods Deluxe Potato Salad due to potential Listeria monocytogenes contamination.

    Product
    Dawn's Foods Deluxe Potato Salad Mfg. No. 20114, Net Wt. 30 lbs. (13.68kg), UPC 10032345201146 Keep Refrigerated between 35 - 38 F. MFG by Dawn's Foods, Portage, WI 53901
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1499-2018·2018-06-06

    Liberty Snacks Honey Roasted Cashews Recalled for Listeria Risk

    Ohio Hickory Harvest is recalling Liberty Snacks Honey Roasted Cashews due to Listeria monocytogenes found in a product stored in the same bin.

    Product
    Liberty Snacks Honey Roasted CASHEWS Net Wt. 1.2 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 [email protected] UPC 8-04879-17154-4
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-2049-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2018·2018-06-06

    Draeger Carina Ventilator Recalled Due to Valve Assembly Corrosion Risk

    Draeger Medical is recalling eight Carina Ventilators because valve assembly corrosion may contaminate breathing gas.

    Product
    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1956-2018·2018-06-06

    Roche MagNA Pure 24 System Recalled for Sample Cross-Contamination

    Roche Molecular Systems is recalling 163 MagNA Pure 24 automated clinical sample extractors due to reported cross-contamination of samples during rack-based purification runs.

    Product
    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk

    Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2018·2018-06-06

    Arrow PSI Kit Recall Due to Potential Sterility Compromise

    Arrow International is recalling 416,055 PSI kits because unsealed packaging may have compromised sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling Sterile Needle Counters because packaging seal creep may compromise sterility. The recall covers 38,464 units distributed in the US, Canada, and other countries.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide