Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

26001–26025 of 32215

SevereFDA (Devices)·Z-1089-2014·2014-03-05
Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk
Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.
Product
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1072-2014·2014-03-05
GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings
GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1551-2014·2014-03-05
UNFI Recalls Kinnikinnick Pancake Mix for Undeclared Milk
UNFI is recalling Kinnikinnick Pancake & Waffle Mix nationwide due to undeclared milk, a major allergen.
Product
Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1055-2014·2014-03-05
Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect
Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.
Product
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1056-2014·2014-03-05
Medline Recalls Surgical Kits with Flaking Guidewire Coating
Medline Industries is recalling 112 surgical kits containing guidewires with a potential for coating to flake off.
Product
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·14V106000·2014-03-05
Daimler Orion VII Transit Buses Recalled for Exhaust Fire Risk
Daimler Buses North America is recalling 2007-2012 Orion VII transit buses because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames.
Product
ORION — ORION VII
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1546-2014·2014-03-05
The Cultured Kitchen Recalls Six Cashew Cheese Varieties Due to Salmonella Risk
The Cultured Kitchen is recalling six varieties of cashew cheese with expiry dates up to April 19, 2014, due to potential Salmonella contamination.
Product
The Cultured Kitchen Pesto or Basil Pesto Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container…
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1047-2014·2014-03-05
Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect
Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.
Product
ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0953-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1545-2014·2014-03-05
The Cultured Kitchen Recalls Cashew Cheese for Salmonella Risk
The Cultured Kitchen is recalling six varieties of cashew cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.
Product
The Cultured Kitchen Habanero Cilantro Lime Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container…
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-0959-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0961-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising airway maintenance.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1070-2014·2014-03-05
GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1105-2014·2014-03-05
Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk
Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.
Product
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1077-2014·2014-03-05
DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Category
Medical Device
Distribution
4 states
SevereFDA (Food)·F-1556-2014·2014-03-05
Unified Grogers Recalls Ginger Snap Cookies for Undeclared Egg
Unified Grocers is recalling 12 oz. Ginger Snap Cookies because they contain undeclared egg. The recall affects products distributed in California, Arizona, and Nevada.
Product
Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1547-2014·2014-03-05
The Cultured Kitchen Recalls White Cheddar Cashew Cheese for Salmonella Risk
The Cultured Kitchen is recalling White Cheddar Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including 4/19/2014.
Product
The Cultured Kitchen White Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC…
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-1052-2014·2014-03-05
Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires
Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.
Product
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·14V087000·2014-03-04
New Flyer Transit Buses Recalled for Potential Exhaust Fire Risk
New Flyer is recalling certain transit buses because condensation in the intake manifold may freeze, causing sensor issues that could lead to exhaust flames or vehicle fires.
Product
NEW FLYER — NEW FLYER C40LF, C40LFR, C35LF, C35LFR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V095000·2014-03-04
Prevost Recalls 2013-2014 Coaches Due to Battery Cable Insulation Defect
Prevost is recalling 59 model year 2013-2014 coaches because defective battery cable insulation may cause the engine to shut down, increasing crash risk.
Product
PREVOST — PREVOST H3-45 VIP, H3-45, H3-41
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V097000·2014-03-04
Ford E-Series CNG Conversion Recall for Rear Cylinder Bracket Failure
Landi Renzo USA is recalling 2011-2014 Ford E-150, E-250, and E-350 vans modified for CNG because rear cylinder brackets may fail, risking a gas leak and fire.
Product
FORD — FORD E-150, E-250, E-350
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V103000·2014-03-04
Fiat 500L Recall: Transmission Shifter May Fail to Shift Gears
Chrysler is recalling 2014 Fiat 500L vehicles because the transmission shifter may not respond to driver input, potentially causing unintended vehicle movement.
Product
FIAT — FIAT 500L
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V085000·2014-02-28
MCI Recalls 2011-2012 D4000 Motorcoaches Due to Fire Risk
Motor Coach Industries is recalling 2011-2012 D4000 motorcoaches because condensation in the intake manifold may freeze, causing sensor failure that leads to exhaust flames or vehicle fire.
Product
MCI — MCI D4000
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V083000·2014-02-27
Blue Bird Recalls School Buses Due to Exhaust Fire Risk
Blue Bird is recalling 2009-2015 All American school buses because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames that increase the risk of fire or burn injury.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V084000·2014-02-27
Gillig Low Floor Transit Bus Recall for Engine Fire Risk
Gillig is recalling 2010-2014 Low Floor transit buses because condensation in the intake manifold may freeze, causing sensor failure and increasing the risk of a vehicle fire.
Product
GILLIG — GILLIG LOW FLOOR
Category
Vehicle
Distribution
Distributed nationwide