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.

9001–9025 of 29123

  • SevereNHTSA·20V663000·2020-10-28

    Daimler Recalls 2015-2020 Sprinter Vans for Steering Hose Defect

    Daimler Vans USA is recalling 2015-2020 Mercedes-Benz and Freightliner Sprinter vans because hydraulic power steering hoses may detach, causing fluid leaks and loss of steering assist.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 1500, SPRINTER 2500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0088-2021·2020-10-28

    Medtronic Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 711 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    Product
    Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a tre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0258-2021·2020-10-28

    ICU Medical Recalls Burette Sets Due to Potential Manufacturing Defect

    ICU Medical is recalling specific lots of 112-inch burette sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.

    Product
    112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709079127(17)250201(30)25(10)4727501. The Intravascular Administration Set is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0255-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect on the NanoClave may prevent a proper seal with the spike.

    Product
    148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0119-2021·2020-10-28

    Olympus Choledoscope Recalled for Lack of Clearance and Breakage

    Olympus is recalling CHF-CB30S choledoscopes because they lack FDA clearance and have experienced breakage and metal protrusion during use.

    Product
    Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0222-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0177-2021·2020-10-28

    Bien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk

    Bien-Air Surgery is recalling 1,120 OsseoDuo multifunction foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0118-2021·2020-10-28

    Smith & Nephew Recalls Genesis Knee Implants Due to Design Defect

    Smith & Nephew is recalling 47 Genesis knee implants because the anterior locking detail does not meet design specifications.

    Product
    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0230-2021·2020-10-28

    ICU Medical Recalls 114-inch Burette Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 114-inch burette sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709091747(17)241201(30)25(10)4476428;(01)10887709091747(17)250101(30)25(10)47128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0131-2021·2020-10-28

    GE Healthcare Recalls PET/MR Imagers Due to Electrical Arc Flash Risk

    GE Healthcare is recalling specific PET/MR imager models due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0129-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0130-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the Power Gradient & RF Cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0128-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

    GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0203-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524. The Intravascular Administration Set is a single use, sterile, non-pyrogenic dev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0127-2021·2020-10-28

    GE Healthcare Recalls MRI Systems Due to Potential Electrical Arc Flash

    GE Healthcare is recalling 30 MRI systems due to a potential electrical arc flash hazard within the Power Gradient & RF cabinet.

    Product
    System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2021·2020-10-28

    Entellus Medical Shaver System Foot Pedal Recalled for Magnet Defect

    Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0179-2021·2020-10-28

    Stryker S2 Mini Foot Pedal Recalled Due to Magnet Defect

    Bien-Air Surgery is recalling Stryker S2 Mini Foot Pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0189-2021·2020-10-28

    ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 9-inch Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 The In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0176-2021·2020-10-28

    Bien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk

    Bien-Air Surgery is recalling 1,120 foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V660000·2020-10-27

    Suspension snap-ring failure could cause wheel separation on Western Star 4700

    Daimler Trucks is recalling certain 2021 Western Star and Freightliner commercial trucks because the steer axle spindle nut snap-ring may be missing or improperly installed, potentially causing wheel separation and increased crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR CASCADIA, 4900, 5700, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V657000·2020-10-27

    2021 Jeep Cherokee Front Lower Control Arm Fracture Recall

    Chrysler is recalling certain 2021 Jeep Cherokee vehicles because the front lower control arms may fracture while driving. This can cause loss of steering control and increase the risk of a crash.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide