The Recall Desk

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.

25576–25600 of 32194

  • SevereFDA (Devices)·Z-1619-2014·2014-05-21

    Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure

    Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.

    Product
    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1317-2014·2014-05-21

    Flawless Beauty Recalls Tatiomax Injection Vials Sold Without FDA Approval

    Flawless Beauty LLC is recalling Tatiomax powder for injection vials because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1321-2014·2014-05-21

    Flawless Beauty Recalls Sterile Water for Injection Sold Without Approval

    Flawless Beauty LLC is recalling Sterile Water for Injection ampoules sold over the counter without an approved NDA or ANDA.

    Product
    Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1947-2014·2014-05-21

    Deb-El Foods Recalls Dried Whole Eggs for Undeclared Milk

    Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk. The affected product was distributed in Mexico, Canada, and Denmark.

    Product
    Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1936-2014·2014-05-21

    Swanson Cilantro Supplement Recalled for Potential Salmonella Contamination

    Swanson Health Products is recalling specific lots of Full Spectrum Cilantro herbal supplements due to a potential risk of salmonella contamination.

    Product
    Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2014·2014-05-21

    CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue

    CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.

    Product
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1933-2014·2014-05-21

    Raw Deal Recalls Adult Herbal Blend 992 Due to Salmonella Risk

    Raw Deal is recalling Adult Herbal Blend 992 because it may contain salmonella. The product was distributed in Connecticut, Utah, and Canada.

    Product
    Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V265000·2014-05-20

    GM Recalls 2015 Silverado HD and Sierra HD for Fire Risk

    General Motors is recalling 2015 Chevrolet Silverado HD and GMC Sierra HD trucks because loose fuse block clips can cause a short circuit and engine compartment fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO HD, SIERRA HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V267000·2014-05-20

    Thor Motor Coach Recalls Outlaw 29H Motorcoaches Due to Fire Risk

    Thor Motor Coach is recalling 2014-2015 Outlaw 29H motorcoaches because the generator exhaust is too close to the propane tank and may release carbon monoxide.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·030-2014·2014-05-19

    Wolverine Packing Recalls Ground Beef Due To Possible E. Coli O157:H7

    Wolverine Packing Company is recalling approximately 1.8 million pounds of ground beef products due to possible E. coli O157:H7 contamination.

    Product
    Wolverine Packing Co. — Michigan Firm Recalls Ground Beef Products Due To Possible E. Coli O157:H7
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E026000·2014-05-19

    Agility Fuel Systems Recalls CNG Tank Rail Mount Systems

    Agility Fuel Systems is recalling CNG Tank Rail Mount Systems manufactured between September 2010 and January 2013. The defect may allow the tank to move, potentially damaging fuel lines and increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:MOUNTING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V262000·2014-05-19

    Suzuki Recalls Forenza and Reno Vehicles for Headlamp Fire Risk

    Suzuki is recalling 2004-2008 Forenza and 2005-2008 Reno vehicles because heat in the headlamp switch or DRL module could melt components and cause a fire.

    Product
    SUZUKI — SUZUKI FORENZA, RENO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2014·2014-05-16

    Transatlantic Foods Recalls Pork and Poultry Products Due to Lack of Inspection

    Transatlantic Foods is recalling approximately 222,000 pounds of pork and poultry products because they were produced without the required USDA inspection.

    Product
    New York Firm Recalls Pork and Poultry Products Due To Lack of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V258000·2014-05-16

    Honda Recalls 2013 Fit Vehicles for Driveshaft Breakage Risk

    Honda is recalling 2013 Fit vehicles with manual transmissions because the passenger side driveshaft may break, potentially causing loss of power or unexpected movement.

    Product
    HONDA — HONDA FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14179·2014-05-15

    Gree Recalls Dehumidifiers Due to Fire and Burn Hazards

    Gree is recalling approximately 2.5 million dehumidifiers in the U.S. and 55,000 in Canada due to fire and burn hazards. Consumers should unplug the units and contact Gree for a refund.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·14184·2014-05-15

    Exmark Recalls Quest ZRT Riding Mowers Due to Steering Failure

    Exmark is recalling 2009 and 2010 Quest ZRT riding mowers because the steering assembly can fail, causing loss of control and crash hazards.

    Product
    Exmark Quest ZRT Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1308-2014·2014-05-14

    Mangiacotti Ginger Lime Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Ginger Lime Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2014·2014-05-14

    Med-Mizer Retractabed Recall for Insufficient Welding on Foot Cross Tube

    Med-Mizer is recalling 191 Retractabed Clinical Contour adjustable beds manufactured before June 7, 2008, due to insufficient welding that could cause bed collapse.

    Product
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1924-2014·2014-05-14

    Bissinger's Dark Chocolate Bunny Ears Recalled for Undeclared Milk Allergen

    Karl Bissinger LLC is recalling Bissinger's Dark Chocolate Bunny Ears because milk chocolate is packaged in dark chocolate packaging without milk listed on the ingredient statement.

    Product
    Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. "point of purchase" display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted…
    Category
    Food
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1561-2014·2014-05-14

    Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • SevereNHTSA·14V246000·2014-05-14

    GM Recalls 2014-2015 Trucks and SUVs for Steering Defect

    General Motors is recalling specific 2014 Chevrolet Silverado, 2014 GMC Sierra, and 2015 Chevrolet Tahoe vehicles because the steering tie rod may not be properly tightened, risking loss of steering.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, TAHOE, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide