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.

13301–13325 of 29186

  • SevereNHTSA·18V788000·2018-11-09

    Eldorado National Recalls 2014-2018 Vans Due to Seat Lock Defect

    Eldorado National is recalling 2014-2018 Aerolite, Aerotech, Impulse, and World Trans vans because foldaway seats may not stay locked during a crash, increasing injury risk.

    Product
    GOSHEN — GOSHEN, ELDORADO IMPULSE, AEROLITE, AEROTECH, WORLD TRANS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19029·2018-11-08

    A. O. Smith Recalls Ultra-Low NOx Water Heaters Due to Fire Hazard

    A. O. Smith is recalling approximately 616,000 gas water heaters because a torn burner screen can cause excess heat and fire if installed on combustible floors.

    Product
    Ultra-Low NOx water heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2019·2018-11-07

    Pharm D Solutions Recalls Caffeine and Sodium Benzoate Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL due to a lack of assurance of sterility. The recall covers 567 milliliters distributed nationwide.

    Product
    Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0143-2019·2018-11-07

    Bi-Mix Injection Recalled Due to Lack of Assurance of Sterility

    Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E100000·2018-11-07

    Dexter Trailer Axle Recall for Insufficient Bearing Grease

    Dexter Axle Company is recalling specific trailer axles because inner hub bearings may lack sufficient grease, risking overheating and failure.

    Product
    POWER TRAIN:AXLE HUBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable because the agency could not ensure the product was sterile.

    Product
    Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0147-2019·2018-11-07

    Pharm D Solutions Recalls Calcium Gluconate Eyewash Due to Sterility Concerns

    Pharm D Solutions is recalling 29 bottles of Calcium Gluconate 1% Eyewash because the company cannot ensure the product is sterile.

    Product
    Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 179 vials of Sermorelin/Ipamorelin powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0184-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 420 vials of Sermorelin/GHRP-2/GHRP-6 powder nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0350-2019·2018-11-07

    Apollo Food Mini Rolls Recalled for Undeclared Eggs

    Apollo Food International Inc. is recalling Mini Rolls due to undeclared eggs. The product was distributed in Massachusetts, New York, and New Jersey.

    Product
    Mini Roll, The product comes in a 2.469 ounce pink plastic package marked with a production date of 2018.03.20 stamped on the back. The product UPC code is 6 946050 104746. Product of China.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0208-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T-106 Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix T-106 aqueous solution because the company cannot ensure the product is sterile.

    Product
    Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0131-2019·2018-11-07

    Avella Recalls Morphine Bags Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 1,360 bags of Morphine in NS due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0297-2019·2018-11-07

    Siemens Multix Fusion Radiographic Systems Recalled for Lifting Column Cable Defect

    Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.

    Product
    Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2019·2018-11-07

    Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 881 vials of HCG Lyopholized 1200 IU Injectable nationwide due to a lack of assurance of sterility.

    Product
    HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0299-2019·2018-11-07

    Siemens Ysio Radiographic Systems Recalled for Potential Tube Arm Drop

    Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube arm to drop unexpectedly during patient positioning.

    Product
    Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Drugs)·D-0138-2019·2018-11-07

    Pharm D Solutions Recalls Ascorbic Acid Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.

    Product
    Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0161-2019·2018-11-07

    Pharm D Solutions Recalls HCG 3000 Unit Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 765 vials of HCG 3000 Unit Powder nationwide due to a lack of assurance of sterility.

    Product
    HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0281-2019·2018-11-07

    Leica BOND Slide Labeler Printers Recalled for Fire Hazard

    Leica Microsystems is recalling BOND Slide Labeler Zebra Printers because the power supply unit may overheat or cause a fire due to an improperly-mixed phosphorus compound.

    Product
    BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0173-2019·2018-11-07

    Pharm D Solutions Recalls Prostaglandin E1 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Prostaglandin E1 150 mcg/mL Injectable because the agency could not ensure the product was sterile.

    Product
    Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0185-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 108 vials of Sermorelin/GHRP-2/Theanine/Mannitol powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0167-2019·2018-11-07

    Pharm D Solutions Recalls Magnesium IV Solution Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Magnesium 40 gm/ns 1000 mL IV solution because there is a lack of assurance of sterility.

    Product
    Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0132-2019·2018-11-07

    Avella Recalls Fentanyl Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL due to a lack of assurance of sterility.

    Product
    Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0201-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling 430 vials of Trimix injection because the company cannot guarantee the product is sterile.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0203-2019·2018-11-07

    Pharm D Solutions Recalls Trimix ST-1 Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix ST-1 aqueous solution because the company cannot ensure the product is sterile.

    Product
    Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
    Category
    Drug
    Distribution
    Distributed nationwide