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.

18976–19000 of 50407

  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21V823000·2021-10-19

    Sutphen Fire Trucks Recalled for Excessively Bright LED Lights

    Sutphen is recalling two fire trucks because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V821000·2021-10-18

    2022 Mitsubishi Outlander Recalled for Defective Center Pillar Welding

    Mitsubishi is recalling one 2022 Outlander due to a welding robot error that may have caused incorrect center pillar welding, reducing crash protection. In a crash event, the reduced body strength may increase the risk of injury.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V815000·2021-10-18

    Ferrara Recalls 2021 Pumper Fire Trucks Due to Lifting Cable Defect

    Ferrara is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables could cause a generator set to fall, posing an injury risk.

    Product
    FERRARA — FERRARA PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V818000·2021-10-18

    Mercedes-Benz Recalls Vehicles for Incorrectly Assembled Seats

    Mercedes-Benz is recalling specific 2020-2021 models because incorrectly assembled seats may not properly restrain occupants during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC, GLS 450, GLE 450, GLE 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V809000·2021-10-15

    2021 Ford Bronco Sport Moonroof Glass May Detach from Vehicle

    Ford is recalling certain 2021 Bronco Sport vehicles because the moonroof glass may not be bonded correctly to the frame and could detach. A detached glass panel could become a road hazard and increase crash risk.

    Product
    FORD — FORD BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V814000·2021-10-15

    2022 KZRV Sporttrek and Stratus Trailers Fire Risk Recall

    KZRV is recalling certain 2022 Sporttrek and Stratus trailers due to improper circuit breaker connections in water heater and fireplace circuits. The incorrect amperage could increase fire risk.

    Product
    KZRV — KZRV STRATUS, SPORTTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V810000·2021-10-15

    Smeal Recalls 2021 Pumper Fire Trucks Due to Lifting Cable Defect

    Smeal Holding, LLC is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables may cause the generator set to fall, increasing injury risk.

    Product
    SMEAL — SMEAL PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V799000·2021-10-14

    Van Hool Buses Recalled for Wheelchair Lift Barrier Defect

    Van Hool is recalling 422 buses because wheelchair lift barriers may fail under force, increasing injury risk.

    Product
    VAN HOOL — VAN HOOL T2145, C2045, CX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V797000·2021-10-14

    2021 Jeep Grand Cherokee High Beam Headlights May Not Activate

    In certain 2021 Jeep Grand Cherokee L vehicles, the high beam headlights will not activate when the lighting switch is in auto position unless the switch is first changed to on. This defect reduces visibility and increases crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2022·2021-10-13

    Cardiosave Hybrid IABP Display Helium Indicator May Misread in Electromagnetic Interference

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2022·2021-10-13

    Contact Lens Solution Recalled for Possible Foreign Material Contamination

    Contamac Solutions is recalling Nutrifill Scleral, Hybrid, and GP Lens Insertion Solution nationwide due to potential foreign material contamination. The solution is used to insert contact lenses and was distributed to all U.S. states and Washington, DC.

    Product
    Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2022·2021-10-13

    Bone Marrow Aspiration Needle Protector Can Dislodge, Posing Needle-Stick Risk

    Bard Peripheral Vascular is recalling REF TIN3015 bone marrow aspiration needles because the needle protector can become fully dislodged, exposing the needle and creating needle-stick injury risk for healthcare workers.

    Product
    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.

    Product
    Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2022·2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Recalled for Potential Leakage

    ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.

    Product
    Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2022·2021-10-13

    Zoll Cool Line IV Disposable Pack Recalled for Potential Leakage Risk

    ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.

    Product
    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2022·2021-10-13

    Zoll ICY intravascular heat exchange catheter kit recalled for potential leaks

    ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2022·2021-10-13

    Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging

    Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.

    Product
    Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
    Category
    Medical Device
    Distribution
    Distributed nationwide