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.

17451–17475 of 53124

  • HighFDA (Devices)·Z-1069-2022·2022-05-18

    Flexible Uretero-Renoscopes Recalled for Inadequate Disinfection

    Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.

    Product
    11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1048-2022·2022-05-18

    Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall

    Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.

    Product
    BF-MP160F: EVIS EXERA Bronchofibervideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V347000·2022-05-18

    Prevost Recalls X3-45 Commuter Vehicles Due to Rearview Mirror Defect

    Prevost is recalling 2020-2022 X3-45 Commuter vehicles because the right-side rearview mirror is positioned incorrectly, obstructing the driver's view and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2022·2022-05-18

    Karl Storz cystoscopes recalled due to inadequate disinfection

    Karl Storz cystoscopes manufactured since January 2018 are recalled because they may not achieve required disinfection levels. Inadequate disinfection could lead to patient infection during urological procedures.

    Product
    CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1050-2022·2022-05-18

    FDA Recalls Unauthorized COVID-19 Antigen Rapid Test Kits

    USA Medical, LLC distributed 2055 COVID-19 antigen test kits nationwide. The tests did not receive FDA Emergency Use Authorization nor were they cleared or approved for commercial distribution.

    Product
    Diagnostic Kit SARS-cCo V Antigen Rapid Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V348000·2022-05-18

    Airstream Travel Trailers: Manual Step May Collapse Due to Fastener Defect

    Airstream is recalling certain 2022-2023 travel trailers with manual steps that may collapse due to a fastener screw pulling through the washer, increasing the risk of injury.

    Product
    AIRSTREAM — AIRSTREAM INTERNATIONAL, POTTERY BARN, GLOBETROTTER, FLYING CLOUD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1049-2022·2022-05-18

    Jerk Dressing Recalled for Salmonella Contamination in Yellow Onion

    Mosaic Food Company is recalling refrigerated Jerk Dressing made with yellow onions that were recalled for Salmonella contamination. The product was distributed in California.

    Product
    Jerk Dressing; Made with Yellow Onion Item number 7028, 7029 Refrigerated
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1049-2022·2022-05-18

    Bronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions

    Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.

    Product
    BF-1TQ180: EVIS EXERA II Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0854-2022·2022-05-18

    Xanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Viatris Inc recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected tablets may not break down properly, potentially reducing medication effectiveness.

    Product
    Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2022·2022-05-18

    CMOS Video Cysto-Urethroscope Disinfection Failure Puts Patients at Infection Risk

    Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.

    Product
    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1068-2022·2022-05-18

    Karl Storz Video Ureteroscopes May Not Be Properly Sterilized

    Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.

    Product
    11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1052-2022·2022-05-18

    Prothrombin Time Reagent Recalled for Quality Control Failures

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.

    Product
    HemosIL ReadiPlasTin, Part No. 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-05182022-01·2022-05-18

    USDA Issues Public Health Alert for Underprocessed Ready-to-Eat Ham

    USDA FSIS issued a public health alert for Great Value Black Forest Ham that may not be fully cooked. Consumers should discard the product.

    Product
    JBS Prepared Foods — FSIS Issues Public Health Alert for Ready-To-Eat Ham Product Due to Possible Processing Deviation
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1042-2022·2022-05-18

    Medtronic IN.PACT Admiral balloon catheters recalled for damaged packaging

    Medtronic is recalling IN.PACT Admiral paclitaxel-coated balloon catheters due to damaged packaging that may result in loss of sterility, affecting approximately 6,035 units worldwide.

    Product
    Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2022·2022-05-18

    ProterixBio SARS-CoV-2 Antibody Test Recalled for Inaccurate Results

    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test kits are being recalled due to insufficient clinical performance data. The FDA determined test results may not be accurate, with potential false positives or false negatives.

    Product
    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0859-2022·2022-05-18

    Hand Sanitizer Product Recalled Due to Acetaldehyde Contamination

    Kill 'Dat Sanitizing Products Hand Sanitizer (1 gallon, Batch 39) recalled because acetaldehyde levels exceed manufacturer specifications. Product distributed in Louisiana.

    Product
    Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02.
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·22V343000·2022-05-17

    2020-2023 Trailstar and Ranger Trail Boat Trailers Recalled for Hub Seizure

    Tracker Marine is recalling 2020-2023 Trailstar and Ranger Trail boat trailers because axle hubs were not tightened properly, which can cause hub seizure and loss of vehicle control.

    Product
    TRAILSTAR — TRAILSTAR, RANGER TRAIL BOAT TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V344000·2022-05-17

    2022 Kia Telluride recall: instrument cluster display may go blank

    Excess adhesive in the instrument cluster circuit board may cause the display to go blank, preventing drivers from seeing critical information and increasing crash risk.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V338000·2022-05-16

    Commercial trucks recalled for incorrect gross axle weight labels

    Daimler Trucks is recalling commercial trucks with incorrect weight-rating labels that could allow unsafe overloading. Dealers will replace the labels free of charge.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4900, 4700, 5700, NEW CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V342000·2022-05-16

    Bowlus Endless Highways Travel Trailers Recalled for Gas Leak Risk

    Bowlus is recalling 2022 Endless Highways travel trailers because damaged burner control valves may cause a gas leak, increasing fire risk.

    Product
    BOWLUS — BOWLUS ENDLESS HIGHWAYS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V341000·2022-05-16

    Utilimaster Walk-in Van Recall for Incorrect Tire Placard Information

    Shyft Group is recalling 2022 Utilimaster Walk-in vans because tire size and pressure labels may be incorrect, potentially leading to improper tire inflation.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide