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.

12801–12825 of 53082

  • HighFDA (Devices)·Z-1702-2023·2023-06-21

    Eye and Ear Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products is recalling Eye and Ear Droppers (Product Code 67082) due to the potential for glass particulate on the dropper bulb's external surface. Consumers should stop using affected units immediately.

    Product
    Eye and Ear Dropper, Product Code 67082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2023·2023-06-21

    Aspira Pleural Drainage Catheter May Fail to Drain Fluid

    Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2023·2023-06-21

    bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

    Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

    Product
    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

    Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

    Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2023·2023-06-21

    Medicine Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.

    Product
    Medicine Dropper, Product Code K508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V437000·2023-06-21

    2023 Volkswagen GTI and Golf R suspension strut mount defect

    Volkswagen is recalling certain 2023 GTI and Golf R vehicles due to deformed suspension strut mounts that may loosen and cause steering instability. Dealers will replace affected components at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN GTI, GOLF R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

    Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0872-2023·2023-06-21

    Hand Sanitizer Recalled Due to Manufacturing Deficiency and Methanol Risk

    Jarman's Midwest Cleaning Systems recalled 1,276 gallons of isopropyl alcohol hand sanitizer nationwide due to manufacturing deficiencies and potential methanol contamination risk found at the production site.

    Product
    Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0986-2023·2023-06-21

    Texas Pete Buffalo Wing Sauce recalled for undeclared soy allergen

    T.W. Garner Food Co. is recalling Texas Pete Buffalo Wing Sauce due to undeclared soybean oil and soy lecithin. The product was distributed to 14 states.

    Product
    Texas Pete BUFFALO Wing Sauce 12 FL OZ - 355 mL TW GARNER FOOD CO. WINSTON-SALEM, NC 27105 UPC 0 75500 10011 6
    Category
    Food
    Distribution
    14 states
  • HighNHTSA·23V434000·2023-06-19

    2023 Tesla Model 3 and Model Y Battery Disconnect Defect Recall

    Tesla is recalling 26 Model 3 and Model Y vehicles from 2023 because the pyrotechnic battery disconnect may fail to isolate the high-voltage battery after a crash, creating a risk of electrical shock.

    Product
    TESLA — TESLA MODEL Y, MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23222·2023-06-15

    Oceanic SCUBA Buoyancy Compensating Devices Recalled for Drowning Hazard

    Huish Outdoors is recalling Oceanic brand SCUBA diving buoyancy compensating devices because the weight pocket handle can break during use, preventing divers from dumping weight in an emergency to surface safely. No injuries have been reported, but 73 broken handles have been documented.

    Product
    SCUBA Diving Buoyancy Compensating Devices OceanPro, Excursion, Hera
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V431000·2023-06-15

    Honda Odyssey, Pilot, Passport Rearview Camera Display Failure Recall

    A faulty MOST cable connector in certain 2018-2023 Honda Odyssey, Pilot, and Passport vehicles may prevent the rearview camera image from displaying, reducing rear visibility and increasing crash risk.

    Product
    HONDA — HONDA PASSPORT, ODYSSEY, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V432000·2023-06-15

    2023 Toyota Camry and Camry Hybrid: Loose Wheel Lug Nuts Risk Detachment

    Toyota is recalling 298 2023 Camry and Camry Hybrid vehicles because lug nuts attaching wheels may be loose, risking wheel detachment and loss of vehicle control. Owners are advised not to drive until dealers repair the issue.

    Product
    TOYOTA — TOYOTA CAMRY HYBRID, CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V428000·2023-06-15

    2023 Grand Design Momentum Toy Hauler Recall: Incorrect Cargo Capacity Label

    Grand Design RV is recalling certain 2023 Momentum toy haulers due to an incorrect Cargo Carrying Capacity label. The mislabeled weight information can lead to vehicle overload, increasing crash risk.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23223·2023-06-15

    Trek Bicycles with Promax Hydraulic Disc Brakes Recalled for Crash Hazard

    Trek Bicycle Corp. is recalling about 96,900 bicycles equipped with Promax hydraulic disc brakes because the brake hose can detach from the brake lever, posing a crash hazard. Trek has received 195 reports of this issue with no injuries reported.

    Product
    Promax hydraulic disc brakes sold on Trek bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0867-2023·2023-06-14

    Eye Drops Recalled: Travoprost Missing Tamper Evidence Seal

    Golden State Medical Supply is recalling Travoprost eye drops due to missing tamper evidence seals on some bottles. The missing seal prevents sterility assurance on 1,920 units distributed nationwide.

    Product
    TRAVOPROST — TRAVOPROST (TRAVOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2023·2023-06-14

    Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

    Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

    Product
    SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2023·2023-06-14

    Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

    Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

    Product
    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2023·2023-06-14

    AVNS ambIT Catheter System Kits Recalled for Missing Air Filter

    Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2023·2023-06-14

    DePuy Mitek surgical anchor inserter may fracture during use

    DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.

    Product
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2023·2023-06-14

    Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.

    Product
    Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
    Category
    Medical Device
    Distribution
    0 states