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.

27951–27975 of 50462

  • HighFDA (Devices)·Z-2802-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2801-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2795-2018·2018-08-22

    Hamilton-C1 Ventilator Recall Due to Control Board Component Defect

    Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective control board component may cause the device to shut down and trigger alarms.

    Product
    Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1797-2018·2018-08-22

    Saratoga Food Specialties Recalls Pizza Hut Seasoning Breadsticks Due to Salmonella Risk

    Saratoga Food Specialties is voluntarily recalling Pizza Hut Seasoning Breadsticks because a supplier recalled dry whey powder due to potential Salmonella presence.

    Product
    Pizza Hut Seasoning Breadstick 10 pound case, 5 X 2 lb. packages per case, Case SKU 6025584 UPC 1 0885251 71131 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V553000·2018-08-22

    Altec Recalls 2017-2018 LS63 Aerial Devices Due to Fuse Placement

    Altec is recalling 2017-2018 LS63 Aerial Devices because an incorrectly placed battery fuse may increase the risk of an electrical short and fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2829-2018·2018-08-22

    Withings Recalls Nokia BPM+ Wireless Blood Pressure Monitors

    Withings is recalling Nokia BPM+ Wireless Blood Pressure Monitors because the devices may not meet requirements for systolic pressure.

    Product
    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2792-2018·2018-08-22

    MegaPower Electrosurgical Generator Recalled for Potential Patient Burns

    Megadyne Medical Products is recalling 8,380 MegaPower Electrosurgical Generators because plugging two devices into the same port can activate both, potentially causing patient burns.

    Product
    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2747-2018·2018-08-22

    Siemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue

    Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.

    Product
    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1827-2018·2018-08-22

    BulkSupplements.com Recalls Glucosamine Sulfate Potassium for Undeclared Shellfish

    Hard Eight Nutrition LLC is recalling two lots of Glucosamine Sulfate Potassium because the product labels failed to declare shellfish as an ingredient.

    Product
    BulkSupplements.com Glucosamine Sulfate Potassium; 100 grams, 250 grams, 500 grams, 1 kilogram; Stand up zipper pouch bags. Directions: As a dietary supplement, take 1000 mg (scant 1/4 tsp) up to three time daily, or as directed by a physician. Distributed exclusively…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2831-2018·2018-08-22

    Beekley S-SPOT REF 777 Mammography Markers Recalled for Imaging Artifacts

    Beekley Corporation is recalling S-SPOT REF 777 and 777S markers because they may create imaging artifacts that mimic calcifications on mammograms.

    Product
    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2018·2018-08-22

    Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference

    Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.

    Product
    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2018·2018-08-22

    Wondfo Recalls T-Cube Oral Fluid Test Cubes Due to Choking Hazard

    Guangzhou Wondfo Biotech is recalling 50,000 T-Cube One Step Multi-Drug Oral Fluid Test Cubes because the saliva collection device may fail, causing the foam tip to dislodge in the user's mouth.

    Product
    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2807-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2744-2018·2018-08-22

    ConvaTec AbViser AutoValve IAP Monitoring Devices Recalled for Sterile Barrier Breach

    ConvaTec is recalling AbViser AutoValve IAP Monitoring Devices because bubble leak testing confirmed a potential pinhole breach in the sterile barrier.

    Product
    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1826-2018·2018-08-22

    Mediterranean Salad Vegan Recalled for Undeclared Milk Allergen

    Market of Choice Inc is recalling pre-packaged Mediterranean Salad Vegan because milk is listed in the ingredients but not in the 'Contains' statement.

    Product
    Mediterranean Salad Vegan, pre-packaged. UPC 0 211004 706991.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2812-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·18V555000·2018-08-22

    Kenworth Trucks Recalled for Missing Engine Warning Light Circuits

    PACCAR is recalling 2016-2019 Kenworth trucks because missing engine harness circuits may prevent warning lights from indicating serious engine problems.

    Product
    KENWORTH — KENWORTH W900, T800, C500, T660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2790-2018·2018-08-22

    FDA Recalls Improve Blood Collection Sets Due to Needle Defects

    Guangzhou Improve Medical Instruments is recalling 700,000 blood collection sets in Puerto Rico due to needle defects including discoloration and gel agglomeration.

    Product
    Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3)…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2828-2018·2018-08-22

    Cypress Medical Recalls Powder Free Vinyl Exam Gloves

    Cypress Medical Products LLC is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because samples failed release specifications, potentially compromising the barrier against infectious material.

    Product
    Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2018·2018-08-22

    Mako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues

    Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.

    Product
    Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2819-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues

    Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states