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.

13051–13075 of 29186

  • SevereFDA (Drugs)·D-0333-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes

    Pharmedium Services, LLC is voluntarily recalling 295 syringes of a fentanyl and ropivacaine injection that were found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0627-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0778-2019·2018-12-26

    Lipari Foods Recalls Inspired Organic Peanut Butter for Listeria

    Lipari Foods Operating Company, LLC is recalling Inspired Organic Peanut Butter after product testing returned positive results for Listeria monocytogenes.

    Product
    Inspired Organic Peanut Butter 16oz. plastic jar, 6 per case UPC #: 863669742588 refrigerate after opening
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0343-2019·2018-12-26

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU due to inadequate processes to assure sterility.

    Product
    Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0774-2019·2018-12-26

    Luckyberry Recalls Unpasteurized Cold-Pressed Juice for Regulatory Violation

    Luckyberry is recalling unpasteurized Mai Tai and Orange Pineapple cold-pressed juices sold in Lawrence, Kansas, due to violations of FDA juice safety regulations.

    Product
    Luckyberry Cold-Pressed Juice, Mai Tai, Orange Pineapple, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0338-2019·2018-12-26

    Gordon Laboratories Recalls Monsel's Solution Due to High Iron Levels

    Gordon Laboratories is recalling specific batches of Monsel's (Ferric Subsulfate) Solution because they contain higher levels of iron than labeled.

    Product
    Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0768-2019·2018-12-26

    Luckyberry Cold-Pressed Juice Recalled for Unpasteurized Juice Violation

    Luckyberry is recalling cold-pressed juice products because they were manufactured and distributed in violation of FDA regulations requiring pasteurization or HACCP compliance.

    Product
    Luckyberry Cold-Pressed Juice, Clean & Clear, Pineapple, Green Apple, Cucumber, Min, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0625-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0734-2019·2018-12-26

    Country Favor Recalls Best Taste Dried Bamboo Shoots for Undeclared Sulfites

    Country Favor Inc. is recalling Best Taste Brand Dried Bamboo Shoots because the product contains undeclared sulfites. The recall affects 81 cases distributed across 23 states.

    Product
    Best Taste Brand DRIED BAMBOO SHOOT Mang Non. The product comes in a 12 ounce (340g) uncoded flexible plastic package with UPC: 6 9709 999 40196. Product of P.R.C.
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0727-2019·2018-12-26

    Achdut Recalls Organic Tahini Products Due to Salmonella Contamination Risk

    Achdut is recalling multiple brands of organic tahini because the product may be contaminated with Salmonella. The recall affects 88,490 units distributed in New York, California, Pennsylvania, and Israel.

    Product
    Organic Tahini sold under the following brand names: Pepperwood organic tahini, 428g, UPC: 860294001400; Pepperwood whole organic tahini, 428 g, UPC: 860294001417; Baron's organic Tahini, 454g, UPC: 816412011059; Galil, organic Tahini, 500g, UPC: 7290000572086; Soom organic…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0334-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate and Ropivacaine HCl injection because the product was found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V928000·2018-12-21

    Prevost Recalls Buses Due to Draglink Fracture Risk

    Prevost is recalling 676 buses because a steering component may fracture, causing a loss of steering and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45, XLII-45, XL-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V930000·2018-12-21

    Thomas Built Saf-T-Liner C2 School Bus Recall for Electrical Overload

    Daimler Trucks is recalling 2019-2020 Thomas Built Saf-T-Liner C2 school buses because an electrical overload may cause the engine to shut down, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V924000·2018-12-21

    Collins Recalls 2018 Buses Due to Improperly Tightened Seat Bolts

    Collins Bus Corporation is recalling 2018 SH, DH, P24, T22, T24, and TH buses because seat bolts may not be properly tightened, increasing injury risk in a crash.

    Product
    COLLINS — COLLINS TH, T22, P24, T24
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V929000·2018-12-21

    Thomas Built Buses Recalls Saf-T-Liner C2 for Electrical Overload Risk

    Daimler Trucks North America is recalling 2019-2020 Thomas Built Saf-T-Liner C2 buses because an electrical overload may cause the engine to shut down, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V927000·2018-12-21

    Harley-Davidson Recalls Street Motorcycles Due to Brake Caliper Corrosion

    Harley-Davidson is recalling 2016-2019 Street 500, 750, and 750A motorcycles because brake calipers may corrode internally, causing increased brake drag and a higher risk of crash.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG500, XG750A, XG750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V921000·2018-12-20

    Honda Recalls 2017-2018 Clarity Fuel Cell for Power Loss Risk

    Honda is recalling 2017-2018 Clarity Fuel Cell vehicles previously repaired under recall 18V-068 because incomplete software updates may cause partial or complete power loss.

    Product
    HONDA — HONDA CLARITY FUEL CELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V914000·2018-12-19

    Thomas Built Buses Recalls School Buses for Loose Steering Bolts

    Daimler Trucks is recalling 2018-2019 Thomas Built Saf-T-Liner school buses because loose steering tie rod arm bolts may separate, affecting steering and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0716-2019·2018-12-19

    Baraka Mild Curry Powder Recalled for High Lead Levels

    U.B.C. Food Distributors is voluntarily recalling Baraka Mild Curry Powder due to high levels of lead found in the product.

    Product
    Baraka Mild Curry Powder packed in 7 oz. Plastic Jar
    Category
    Food
    Distribution
    9 states