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.

31776–31800 of 50502

  • HighFDA (Devices)·Z-2723-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 1,100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-2470-2017·2017-07-19

    Greencore USA Recalls Tuna Salad Sandwiches Due to Undeclared Milk Allergen

    Greencore USA is recalling specific Tuna Salad Sandwiches because they contain undeclared milk, a major food allergen.

    Product
    Tuna Salad Sandwich under the following labels: Enzas Choice Tuna Salad on Wheat Bread, 6.6 0z UPC 73508757486 Hannaford Tuna Salad on Club Roll, 5.1 0z UPC 41268165889
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2553-2017·2017-07-19

    National Fish & Seafood Recalls Flounder Fillets for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Matlaws flounder fillets because they may contain undeclared milk. The product was distributed in 24 states.

    Product
    MATLAWS R/B FLOUNDER PANKO FLTS 2-3 OZ 1/10 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2718-2017·2017-07-19

    ICU Medical Recalls 28 cm Bifuse Extension Sets Due to Leak Risk

    ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2703-2017·2017-07-19

    GE Healthcare Recalls Carestation Monitors for Potential Malfunction

    GE Healthcare is recalling Carestation 620, 650, and 650c monitors due to potential for elevated FiCO2 readings and unexpected system malfunctions.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-2471-2017·2017-07-19

    GreenCore USA Recalls Ham Salad Sandwiches for Undeclared Milk Allergen

    GreenCore USA is recalling 17,123 ham salad sandwiches sold in Maine, New York, and Pennsylvania because they contain undeclared milk.

    Product
    Ham Salad Sandwich under the following labels: Enza's Choice Ham Salad on Wheat Bread, 6.6 oz. UPC 73508758165. Hannaford Ham Salad on Club Roll, 5.1 oz . UPC 41268165896. Turkey Hill Fresh Selects Ham Salad on homestyle bread, 4.9 oz. UPC 7350875003
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2675-2017·2017-07-19

    ICU Recalls 180 Plum A+ Infusion Systems Due to Battery Issues

    ICU is recalling 180 Plum A+ Infusion Systems because battery issues may cause an E321 error code and interrupt therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2709-2017·2017-07-19

    Toshiba XARIO 200 Ultrasound System Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems is recalling XARIO 200 diagnostic ultrasound systems because the Continuous Trace method may display incorrect velocity trace values.

    Product
    XARIO 200 TUS-X200 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2697-2017·2017-07-19

    Elekta Leksell Gamma Knife Icon Recall for Electrical Safety Risk

    Elekta is recalling two Leksell Gamma Knife Icon units due to a potential electrical safety risk for technicians performing maintenance.

    Product
    Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2713-2017·2017-07-19

    Pentax Video Duodenoscope Recall for Surface Soiling Investigation

    Pentax of America Inc. issued a field correction for two Video Duodenoscope models to investigate surface soiling on the suction cylinder and distal cap.

    Product
    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2569-2017·2017-07-19

    National Fish & Seafood Recalls Perch Fillets for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Schooner Pre-Cooked Crunchy Perch Fillets because the product may contain undeclared milk.

    Product
    SCHOONER PRE-COOKED CRUNCHY PERCH FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2719-2017·2017-07-19

    ICU Medical Recalls 28 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 6 units of 28 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2728-2017·2017-07-19

    Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise

    Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask heart rate and blood flow sounds.

    Product
    Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2720-2017·2017-07-19

    ICU Medical Recalls Proximale Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 70 units of Proximale Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-2556-2017·2017-07-19

    Murrys Pre-Cooked Steaks Recalled for Undeclared Milk Allergen

    National Fish & Seafood, Inc. is recalling specific lots of Murrys Pre-Cooked Steaks because the product may contain undeclared milk.

    Product
    MURRYS PRE COOKED STEAKS 6/2.4 3.2 OZ, 9/4 3.2 OZ
    Category
    Food
    Distribution
    24 states