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.

31751–31775 of 50502

  • HighFDA (Devices)·Z-2705-2017·2017-07-19

    O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction

    O-Two Medical Technologies is recalling Adult Ventilation Timers because the flash rate may be twice the labeled rate, potentially affecting ventilation guidance.

    Product
    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2017·2017-07-19

    Natus Neurology Recalls Elite 5 MHz Vascular Probes Due to Noise Issues

    Natus Neurology is recalling 2,335 Elite 5 MHz Vascular Probes because excessive background noise may mask heart rate and blood flow signals.

    Product
    Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. 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 (Food)·F-2544-2017·2017-07-19

    Falcon Baie Precooked Fish Portions Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Falcon Baie brand precooked fish portions because they may contain undeclared milk.

    Product
    FALCON BAIE BRAND PRECOOKED FISH PORTIONS MADE FROM MINCED FISH NET WT. 10 LB (4.54 Kg) 3 OZ 4/2.5 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2695-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling Plum A+ Infusion Systems because battery issues can cause 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-2558-2017·2017-07-19

    National Pre-Cooked Cod Portions Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling pre-cooked cod portions that may contain undeclared milk. The product was distributed to 24 states.

    Product
    NATIONAL PRE COOKED COD PORTIONS 4 OZ PUFI 10 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2694-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2700-2017·2017-07-19

    CareFusion Recalls Alaris Pump Module 8100 Due to Latch Design Risk

    CareFusion 303, Inc. is recalling 35,940 Alaris Pump Module model 8100 units in the US and Canada due to a potential risk of unintended flow caused by the sear door latch design.

    Product
    Alaris Pump Module model 8100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2568-2017·2017-07-19

    Schooner Pre-Cooked Flounder Fillets Recalled for Undeclared Milk

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

    Product
    SCHOONER PRE-COOKED CRUNCHY FLOUNDER FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2459-2017·2017-07-19

    LJA Enterprises Recalls Nutman Milk Chocolate Pretzels for Undeclared Soy

    LJA Enterprises is recalling 20 bags of Nutman Milk Chocolate Pretzels because the product failed to declare soy as an allergen. The product was distributed in Ohio.

    Product
    NUTMAN MILK CHOCOLATE PRETZELS Net Wt. 4 oz (12 g) bag Ing: Milk Chocolat (Sugar, Cocoa Butter, Whole Milk, Chocolate Liquor***Lecithin (emulsifier) Vamillim (artificial flavor), Pretzels Soft Red Wheat Flour, Corn Syrup, Salt, Baking Soda, /Yeast MANUFACTURED IN A FIRM THAT…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2731-2017·2017-07-19

    O-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns

    O-Two Medical Technologies is voluntarily recalling specific lots of Burn Relief hydrogel dressings because there is a lack of evidence validating the sterilization dose, posing a potential contamination risk.

    Product
    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2543-2017·2017-07-19

    Americas Choice Beer Battered Shrimp Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Americas Choice Beer Battered Shrimp because the product may contain undeclared milk.

    Product
    AMERICAS CHOICE B/D SHRIMP BEER BATTERED POPCORN 12/14 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2696-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 40 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices during medical procedures may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2717-2017·2017-07-19

    ICU Medical Recalls Smallbore Extension Sets Due to Potential Leak

    ICU Medical is recalling 120 units of smallbore extension sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, 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…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0973-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 295,200 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2017·2017-07-19

    ICU Recalls 71 Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 71 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 (Devices)·Z-2681-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 21,703 Plum A+ Infusion Systems because battery issues can cause 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 (Devices)·Z-2676-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption

    ICU is recalling 10,609 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient 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