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.

17926–17950 of 50404

  • HighFDA (Devices)·Z-0709-2022·2022-03-09

    Lacrimedics Collagen Plugs recalled for potential sterility seal compromise

    Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.

    Product
    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2022·2022-03-09

    Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

    Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2022·2022-03-09

    AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples

    Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.

    Product
    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
    Category
    Medical Device
    Distribution
    50 states
  • HighNHTSA·22V138000·2022-03-08

    Terex Recalls 2016-2021 Aerial Devices Due to Emergency Stop Defect

    Terex is recalling 2016-2021 OM, Optima-HRX, and TCX aerial devices because emergency stop controls may fail to stop all boom functions, increasing injury risk.

    Product
    TEREX — TEREX OPTIMA TCX, OPTIMA HRX, OM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V135000·2022-03-08

    2022 Forest River Cardinal travel trailers recalled for electrical fire risk

    Forest River is recalling certain 2022 Cardinal and related travel trailers due to a loose wire cord at the 50AMP shore power inlet that may cause an electrical short and fire.

    Product
    COACHMEN — COACHMEN, FOREST RIVER FREEDOM EXPRESS, CHEROKEE, SABRE, APEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V127000·2022-03-04

    2022 Kia Sorento Vehicles Recalled for Seatbelt Pretensioner Defect

    Kia is recalling 2022 Sorento Hybrid and Sorento PHEV vehicles because the front seatbelt pretensioner(s) may explode during a crash, potentially projecting metal fragments at occupants. Dealers will replace the pretensioners at no cost.

    Product
    KIA — KIA SORENTO HYBRID, SORENTO PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V128000·2022-03-04

    Hino Recalls 2022 NJ7A Trucks Due to Air Brake Fastener Issue

    Hino is recalling 2022 NJ7A vehicles because an improperly tightened air compressor nut may cause low air pressure, potentially triggering the parking brake and increasing crash risk.

    Product
    HINO — HINO NJ7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V123000·2022-03-03

    2022 Hyundai Elantra and Elantra HEV Seat Belt Pretensioner Explosion Hazard

    Hyundai is recalling 2022 Elantra and Elantra HEV vehicles because the front passenger-side seat belt pretensioner may explode during a crash, projecting metal fragments that could strike and injure vehicle occupants.

    Product
    HYUNDAI — HYUNDAI ELANTRA, ELANTRA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V121000·2022-03-03

    Motorhome tire valve stem may lose pressure, increasing crash risk

    Jayco and Entegra motorhomes from 2018–2023 may have defective tire valve stem extensions that contact the wheel rim, causing damage and potential tire pressure loss that increases crash risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO ACCOLADE, ACCOLADE XL, SENECA PRESTIGE, SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E016000·2022-03-03

    Pony.ai Recalls Automated Driving Systems Due to Software Shutdown Risk

    Pony.ai is recalling specific Automated Driving Systems (ADS) because a software error may cause the system to shut down unexpectedly while the vehicle is moving.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V122000·2022-03-03

    Kawasaki Recalls W800 Motorcycles Due to Horn Harness Defect

    Kawasaki is recalling 2019-2022 W800 motorcycles because the horn harness may break, rendering the horn inoperable and increasing crash risk.

    Product
    KAWASAKI — KAWASAKI W800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22732·2022-03-03

    Ski-Doo Snowmobiles Recalled Due to Fire Hazard

    About 700 Ski-Doo snowmobiles from 2020–2022 are recalled because fuel can leak from the tank vent onto hot components when tilted or flipped, posing a fire hazard. BRP has received five reports of fires but no injuries.

    Product
    Ski-Doo Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion

    Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2022·2022-03-02

    BD Vacutainer Luer Lok Access Device may shed particles causing false test results

    BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.

    Product
    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2022·2022-03-02

    Hip implant revision system recalled due to inadequate coating adhesion

    Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.

    Product
    Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2022·2022-03-02

    NobelReplace dental implant components recalled for driver engagement defect

    Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.

    Product
    NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22091·2022-03-02

    Petzl PIRANA Descender Canyoneering Devices Recalled for Drowning Risk

    Petzl is recalling about 3,450 PIRANA descender canyoneering devices because the rope can get caught in the blocking slot, stopping or suspending the climber and creating a drowning risk under waterfalls or pools.

    Product
    PIRANA descender canyoneering devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2022·2022-03-02

    RESODURA Matrix Onlay Recalled Due to Unsealed Packaging

    Collagen Matrix is recalling RESODURA matrix onlay dural substitutes due to outer packaging that is not properly sealed, potentially compromising sterility and creating a risk of infection.

    Product
    RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Coating Adhesion Defect

    Biomet recalls 9 Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion defects. An incorrect rework process may have compromised the porous plasma coating adhesion strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2022·2022-03-02

    Shoulder Implant Stem Coating Defect Due to Invalid Rework Process

    Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0661-2022·2022-03-02

    Video Camera Ceiling Tile Kits May Fall in Some Installations

    Natus Neurology is recalling IPELA FHD PTZ tile kits that may not fit properly in thinner ceiling tile grids and could suddenly fall, creating a safety hazard.

    Product
    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2022·2022-03-02

    Shoulder Implant Stem Recalled for Defective Coating Adhesion

    Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
    Category
    Medical Device
    Distribution
    Distributed nationwide