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.

22726–22750 of 50430

  • HighFDA (Devices)·Z-2493-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and…
    Category
    Medical Device
    Distribution
    46 states
  • HighNHTSA·20V410000·2020-07-15

    Toyota Recalls 2018-2020 Tundra for Dim Turn Signals

    Toyota is recalling 2018-2020 Tundra trucks with LED headlights because a wiring error causes front turn signals to flash too dimly, potentially increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2544-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect

    Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.

    Product
    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V405000·2020-07-14

    Jayco Recalls 2016-2018 Motorhomes Due to Leveling System Bracket Failure

    Jayco is recalling specific 2016-2018 motorhomes because a mounting bracket for the leveling system may fail, allowing components to contact the ground and increasing crash risk.

    Product
    JAYCO — JAYCO REDHAWK, GREYHAWK, ENVOY 200, ENVOY 100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V403000·2020-07-13

    Mitsubishi Outlander Recall: Second-Row Seat Belt Buckle Interference

    Mitsubishi is recalling 2014-2019 Outlander and 2018-2019 Outlander PHEV vehicles because the second-row center seat belt buckle may interfere with the right-side buckle, rendering it inoperable.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER PHEV, OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20761·2020-07-09

    RH Recalls Riveted Mesh Floor Lamps Due to Fire Hazard

    RH is recalling Riveted Mesh Floor Lamps because the foot switch can overheat or catch fire. Consumers should stop using the lamps and contact RH for a refund.

    Product
    Riveted Mesh Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20759·2020-07-09

    Ananda Apothecary Recalls Essential Oils Due to Non-Child-Resistant Packaging

    Ananda Apothecary is recalling four essential oil products because their packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    Wintergreen 100% Pure Essential Oil, Sweet Birch 100% Pure Essential Oil, Super Soother Pure Essential Oil Blend, and Breathe Deep Pure Essential Oil Blend
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1014-2020·2020-07-08

    Brill Frozen Cookie Dough Recalled for Undeclared Walnuts

    Brill Inc. is recalling 252 cases of frozen cookie dough because the product may contain undeclared walnuts, a major food allergen.

    Product
    Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini colored candy pieces frozen cookie dough, MDM # 10194626, Manufactured by Brill, Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2020·2020-07-08

    LivaNova Recalls 220 Units of 3/8 Inch Y Connectors

    LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.

    Product
    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2462-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.

    Product
    1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2453-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2433-2020·2020-07-08

    Codan Swan-Lock Needlefree Connectors Recalled for Potential Sterility Compromise

    Codan US Corporation is recalling 34,776 units of Swan-Lock Swabable Needlefree Connectors because individual packages may have incomplete or bad seals that could compromise sterility.

    Product
    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2442-2020·2020-07-08

    Elekta Leksell Vantage Stereotactic System Recall for Locking Mechanism Defect

    Elekta is recalling 51 Leksell Vantage Stereotactic Systems because the locking mechanism at the Instrument Carrier and Arc interface may not function properly.

    Product
    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2443-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2479-2020·2020-07-08

    Preventice BodyGuardian Heart Remote Monitoring Kit Recalled for Data Accuracy Issues

    Preventice Services is recalling eight BodyGuardian Heart Remote Monitoring Kits because unvalidated software may cause inaccurate data collection, making patient reports unreliable for condition evaluation.

    Product
    BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E047000·2020-07-08

    TAP Recalls Rubicon Express Suspension Lift Kits for Jeep Gladiator

    TAP Worldwide is recalling certain Rubicon Express suspension lift kits for 2020-2021 Jeep Gladiators because the fitment guide inaccurately lists 40-inch tires as compatible, which can affect vehicle stability.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide