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.

12326–12350 of 29164

  • SevereFDA (Devices)·Z-1042-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1072-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1203-2019·2019-04-03

    Bauer's Candies Recalls QVC Christmas Bags Due to Hepatitis A Risk

    Bauer's Candies is recalling QVC 3/8 oz Christmas bags due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    QVC 3/8 oz bags for Christmas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1070-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk

    ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1206-2019·2019-04-03

    Bauer's Candies Recalls 8 oz Modjeskas Due to Hepatitis A Risk

    Bauer's Candies is recalling 8 oz assorted modjeskas and chocolate modjeskas due to a risk of Hepatitis A exposure. The products were distributed to retail locations in Kentucky and Illinois and to private individuals in 27 states and Iceland.

    Product
    8 oz assorted modjeska/chocolate modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1204-2019·2019-04-03

    Bauer's Candies Recalls Salted Combo Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 1 lb salted combo modjeskas due to a risk of Hepatitis A exposure. The product was distributed to retail locations in Kentucky and Illinois, and to private individuals in multiple states and Iceland.

    Product
    1 lb salted combo modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1191-2019·2019-04-03

    Fullei Fresh Organic Mung Bean Sprouts Recalled for Listeria Risk

    Kwokcheng Enterprise is recalling Fullei Fresh Organic Mung Bean Sprouts due to potential Listeria monocytogenes contamination. The product was distributed to Whole Foods in Florida and Freedom Fresh in Miami.

    Product
    Fullei Fresh brand Organic Mung Bean Sprouts in a 4 oz. clear plastic clamshell container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1192-2019·2019-04-03

    Soom Chocolate Tahini Halva Spread Recalled for Salmonella Risk

    Soom Foods is recalling 1oz Chocolate Sweet Tahini Halva Spread squeeze packs because Salmonella was found in a sample by the contracted manufacturer.

    Product
    Soom Chocolate Sweet Tahini Halva Spread 30 ml ( 1oz )Squeeze Pack
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1044-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1202-2019·2019-04-03

    Bauer's Candies Recalls Salted Combo Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 1 lb salted combo modjeskas due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    1 lb salted combo modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1195-2019·2019-04-03

    Bauer's Candies Recalls Sea Salt Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling Sea Salt Modjeskas due to a risk of Hepatitis A exposure. The candy was distributed to retail locations and private individuals in multiple states.

    Product
    Sea Salt Bauer's Candies Modjeskas NET WT 8 oz bag, bulk, 4 oz bag, 1 lb, 2 lb, 8 oz box
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1201-2019·2019-04-03

    Bauer's Candies Recalls Candy Combos Due to Hepatitis A Exposure Risk

    Bauer's Candies, Inc. is recalling various candy combos due to a risk of Hepatitis A exposure. The products were distributed to retail locations and private individuals in multiple states.

    Product
    1 lb QVC combo, 1 lb combo, 2 lb combo, 12 oz combo, 8 oz combo, holiday combo
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1199-2019·2019-04-03

    Bauer's Candies Recalls Bulk Chocolate Caramels Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling bulk chocolate caramels due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    bulk chocolate caramels
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1194-2019·2019-04-03

    Bauer's Chocolate Modjeskas Recalled for Hepatitis A Exposure Risk

    Bauer's Candies is recalling Chocolate Modjeskas due to a risk of Hepatitis A exposure. The products were distributed to retail locations and private individuals in multiple states.

    Product
    Bauer's Candies Chocolate Modjeskas NET WT 4 oz & 8 oz bags, 8 oz box, bulk, & 1 lb box
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1198-2019·2019-04-03

    Bauer's Candies Recalls Bulk Assorted Candy Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 2 cases of bulk assorted candy due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    Bulk assorted
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1053-2019·2019-04-03

    Philips UroDiagnost MRF Recall Due to Missing Locking Plate

    Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V265000·2019-04-02

    Entegra Recalls 2019 Vision and Emblem Motorhomes for Fire Risk

    Entegra Coach is recalling 2019 Vision and Emblem motorhomes because a missing fuse in the blower motor circuit may cause wiring to overheat and increase the risk of fire.

    Product
    ENTEGRA — ENTEGRA VISION, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V260000·2019-04-01

    Labrie CNG Refuse Trucks Recalled for Valve Stem Ejection Risk

    Labrie is recalling 2017-2018 Automizer and Expert CNG refuse trucks because valve stems may forcibly eject, posing injury and fire risks.

    Product
    LABRIE — LABRIE AUTOMIZER, EXPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·039-2019·2019-03-30

    Market of Choice Recalls Pork and Poultry Pâté for Undeclared Allergens

    Market of Choice is recalling pork and poultry pâté products containing undeclared milk and soy allergens. No adverse reactions have been reported.

    Product
    Market of Choice, Inc. Recalls Pork and Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V258000·2019-03-29

    Forest River Recalls 2017-2019 Rockport Work Trucks for Fire Risk

    Forest River is recalling 2017-2019 Rockport work trucks because a missing inline fuse may allow excess current to melt wiring, increasing the risk of a fire.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V253000·2019-03-28

    Genie Recalls 2019 TZ-34 and TZ-50 Aerial Devices for Fire Risk

    Genie is recalling 2019 TZ-34 and TZ-50 trailer-mounted aerial devices because improperly crimped battery cables may overheat and cause a fire.

    Product
    GENIE — GENIE TZ-34, TZ-50
    Category
    Vehicle
    Distribution
    Distributed nationwide