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.

20651–20675 of 32121

  • SevereFDA (Devices)·Z-0804-2016·2016-03-02

    Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues

    Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.

    Product
    Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0866-2016·2016-03-02

    GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk

    GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.

    Product
    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0631-2016·2016-03-02

    Mahina Mele Farm Recalls Raw Mac Nut Butter Due to Salmonella

    Mahina Mele Farm is recalling Baby Bruddah's Mac Nut Buttah because samples of raw macadamia nuts tested positive for Salmonella.

    Product
    Baby Bruddah's Mac Nut Buttah; Certified Organic by International Certification Services Inc.. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 753182242019 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0726-2016·2016-03-02

    Keystone Recalls Medicated Better Braids Spray Due to Staphylococcus aureus

    Keystone Laboratories is recalling Medicated Better Braids, La Laque (salicylic acid) Spray due to a positive Staphylococcus aureus test result.

    Product
    Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0623-2016·2016-03-02

    Purple Cow Cookie Butter Ice Cream Recalled for Mislabeling

    House of Flavors is recalling Purple Cow Limited Edition Cookie Butter Ice Cream because the cups contain Butter Pecan ice cream instead.

    Product
    Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0624-2016·2016-03-02

    CSFPDX Recalls Wild Albacore Tuna Cans Due to Under-Processing Concerns

    CSFPDX, LLC is voluntarily recalling 142 cans of Wild Albacore Tuna because they may be under-processed, posing a risk of Clostridium botulinum contamination.

    Product
    Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is black ink on an off white label. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V128000·2016-03-02

    Toyota and Lexus Recall Vehicles for Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2008-2010 Lexus SC, Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the passenger air bag inflator may rupture during deployment.

    Product
    LEXUS — LEXUS, TOYOTA, PONTIAC SC, COROLLA MATRIX, COROLLA, VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V122000·2016-03-01

    Maserati Recalls Ghibli and Quattroporte Due to Floor Mat Defect

    Maserati is recalling 2014-2016 Ghibli and Quattroporte vehicles because the driver-side floor mat anchor may break, allowing the mat to trap the accelerator pedal.

    Product
    MASERATI — MASERATI GHIBLI, QUATTROPORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V120000·2016-02-29

    Jayco Eagle Trailers Recalled for Unprotected Solar Battery Cable Fire Risk

    Jayco is recalling 2016 Eagle fifth wheels and travel trailers because an unprotected solar battery cable may short circuit and cause a fire.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO FIFTH WHEEL EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V113000·2016-02-26

    Chrysler Recalls 2015-2016 Dodge Dart Vehicles for Software Defect

    Chrysler is recalling certain 2015 and 2016 Dodge Dart vehicles because a missing software backup in the powertrain control module may increase the risk of a crash.

    Product
    DODGE — DODGE DART
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V109000·2016-02-25

    Honda Recalls 2014 NSS300 Scooters for Rear Brake Line Leak

    Honda is recalling 2014 NSS300 and NSS300A scooters because improperly tightened rear brake lines may leak fluid, reducing braking function and increasing crash risk.

    Product
    HONDA — HONDA NSS300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V112000·2016-02-25

    Open Range Journeyer Trailers Recalled for Underrated Safety Chains

    Open Range is recalling 2012-2015 Journeyer trailers because the safety chains are not rated high enough to support the trailer's weight if the main connection fails.

    Product
    OPEN RANGE — OPEN RANGE JOURNEYER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0699-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after an FDA inspection identified concerns regarding the lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0819-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles

    Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.

    Product
    Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0702-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0692-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0701-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0705-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products containing papaverine, phentolamine, and prostaglandin due to FDA inspection findings regarding sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0706-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding the assurance of sterility.

    Product
    papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0708-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, after FDA inspection found lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0716-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded testosterone cypionate because an FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0680-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 10 mg/mL, after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V108000·2016-02-24

    GM Recalls 2016 Buick Regal for Power Steering Failure Risk

    General Motors is recalling 2016 Buick Regal vehicles because the power-steering assist system may fail, increasing crash risk.

    Product
    BUICK — BUICK REGAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0822-2016·2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles in Best Practice Kits

    Medtronic is recalling 2,711 Best Practice Kits containing specific Endo GIA Ultra Universal Stapler Handles due to reports of staplers failing to fire or partially firing, and articulating levers disengaging during use.

    Product
    Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and…
    Category
    Medical Device
    Distribution
    Distributed nationwide