The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

5076–5100 of 29102

  • SevereFDA (Devices)·Z-1460-2023·2023-05-24

    Anesthesia circuit kit may detach during ventilation due to loose glued connections

    Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.

    Product
    Anesthesia Circuit Kit Coax HEPA, MP17102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.

    Product
    ASM Replacement Battery, Component Number SUB0000594
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1455-2023·2023-05-24

    Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach

    Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.

    Product
    Ventstar Coax 180, MP03374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1451-2023·2023-05-24

    VentStar Coax breathing circuit connections recalled for detachment risk

    Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

    Product
    VentStar Coax (P) 150, MP00379
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2023·2023-05-24

    VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment

    Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.

    Product
    VentStar Basic (N) 180, MP00353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2023·2023-05-24

    Ventstar Coax 230 breathing circuit connections can detach during ventilation

    The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

    Product
    Ventstar Coax 230, MP03376
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1450-2023·2023-05-24

    Draeger VentStar Breathing Circuit Connections May Loosen During Use

    Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.

    Product
    VentStar Bag Set (N) 110, MP00383
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1442-2023·2023-05-24

    VentStar Watertrap Breathing Circuit Connections May Detach During Use

    Draeger Medical recalls VentStar Watertrap (P) 180 breathing circuit equipment because glued connections can become loose or detach before or during ventilation.

    Product
    VentStar Watertrap (P) 180, MP00361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.

    Product
    ASM Replacement Battery, Component Number SUB0000864
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1565-2023·2023-05-24

    Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

    ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0892-2023·2023-05-24

    Oregon Nut Blend Recalled for Undeclared Almonds and Cashews

    Willamette Hazelnut, Inc. is recalling Oregon Nut Blend because it contains undeclared almonds and cashews. This poses a risk to consumers allergic to these nuts.

    Product
    Oregon Nut Blend, Item # 5180808, Packed in cardboard box with poly liner; net wt. 25 lbs. No UPC. Label declares: Oregon Nut Blend, Innovative Bakery Resources. Ingredients: Hazelnuts, Walnuts. Product of USA. Manufactured By: Ardent Mills Tualatin, OR.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1446-2023·2023-05-24

    ID Circuit Basic breathing circuit recalled for loose glued connections

    Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    ID Circuit Basic (P) 180, MP01340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2023·2023-05-24

    Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

    ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

    Product
    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1441-2023·2023-05-24

    VentStar Basic ventilator breathing circuit connections may detach

    Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.

    Product
    VentStar Basic (P)250, MP00352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V361000·2023-05-22

    Polestar Recalls 2020-2021 Polestar 1 Vehicles Due to Battery Fire Risk

    Polestar is recalling 2020-2021 Polestar 1 vehicles because defective high-voltage battery cells may overheat and cause a fire. Dealers will replace the battery pack free of charge.

    Product
    POLESTAR — POLESTAR POLESTAR 1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V354000·2023-05-18

    Tico Spotter B 6.7 Trucks Recalled for Steering Gear Fracture Risk

    Terminal Investment Corporation is recalling 2022-2023 Tico Spotter B 6.7 trucks because incorrectly assembled steering gears may fracture, causing loss of steering control.

    Product
    TICO — TICO SPOTTER B 6.7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23205·2023-05-18

    PowerXL Stuffed Wafflizer Waffle Makers Recalled for Burn Hazard

    About 456,000 PowerXL Stuffed Wafflizer waffle makers are being recalled because hot pieces of waffle or stuffing can be expelled during use or when opening the product, creating a burn risk. The firm has received 44 incident reports, including 34 burn injuries with three requiring medical attention.

    Product
    PowerXL Stuffed Wafflizer waffle makers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23204·2023-05-18

    Target Recalls 4.9 Million Threshold Glass Jar Candles for Laceration and Burn Risk

    Target is recalling approximately 4.9 million Threshold Glass Jar Candles because the glass jar can crack or break during use, posing laceration and burn hazards. Six injuries, including lacerations and severe burns, have been reported.

    Product
    Threshold Glass Jar Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23760·2023-05-18

    Polaris RZR Pro XP and Turbo R vehicles recalled due to fuel leak fire hazard

    Polaris is recalling about 20,330 Model Year 2021–2023 RZR Pro XP 4 and Model Year 2022–2023 RZR Turbo R 4 recreational off-road vehicles because a fuel leak at the fuel pump assembly can occur near a hot surface, posing a fire hazard. The company has received five reports of fuel leaks, including one report of fire.

    Product
    Model Year 2021-2023 RZR Pro XP 4 and Model Year 2022-2023 RZR Turbo R 4 vehicles Recreational Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23207·2023-05-18

    BQQZHZ Combination Smoke and Carbon Monoxide Detectors May Fail to Alert

    The CPSC is warning consumers to stop using BQQZHZ combination smoke and carbon monoxide detectors immediately because they can fail to alert to hazardous smoke and fire. About 25,000 units sold on Amazon.com are affected.

    Product
    BQQZHZ Combination Smoke and Carbon Monoxide Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide