The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

8226–8250 of 29123

  • SevereCPSC·21138·2021-05-26

    HSN Recalls 5.4 Million Handheld Clothing Steamers Due to Burn Hazard

    HSN is recalling 5.4 million Joy/JM-branded My Little Steamer handheld clothing steamers because they can expel hot water, posing a serious burn hazard.

    Product
    Joy/JM-branded My Little Steamer® and My Little Steamer® Go Mini
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0547-2021·2021-05-26

    FDA Recall: Enoki Mushrooms Tested Positive for Listeria Monocytogenes

    Massachusetts sampling detected Listeria monocytogenes in Guan's Enoki Mushrooms, prompting a nationwide recall.

    Product
    Guan's Enoki Mushroom; Champignon d'enoki 100 g/3.5 oz. and 200 g/7 oz. packages. Clear package with blue band at bottom of front and back of package. UPC 100g: 859267007020; UPC 200g: 810023170303. Keep refrigeratedL Distributed by Guan's Mushroom, Los Angeles, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0505-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph Whey Protein for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Smores dietary supplement because it contains undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE SMORES DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89002 7 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0383-2021·2021-05-26

    FDA Recalls Triple SupremeZen Plus 3500 for Unapproved Tadalafil

    Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2021·2021-05-26

    BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

    BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

    Product
    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns

    Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0497-2021·2021-05-26

    A Life African Market Recalls Unlabeled Shrayy Chalk for Lead and Arsenic

    A Life African Market Corp is recalling 344 lbs of unlabeled Shrayy white chalk found to contain elevated levels of lead and arsenic. The product was distributed in New York, Delaware, Massachusetts, and Pennsylvania.

    Product
    Shrayy (white chalk) packaged in .68lb bags of synthetic plastic; no label on packaging
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0549-2021·2021-05-26

    Faribault Foods Recalls O Organics Organic Black Beans Due to Seal Defects

    Faribault Foods is recalling O Organics Organic Black Beans because of compromised hermetic seals on the cans. Consumers should check their pantry for the specific UPC and best-by date.

    Product
    O Organics Organic Black Beans, 15 oz. can, UPC 0-79893-40610-7 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, 1-800-232-4271
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0378-2021·2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee the product is sterile.

    Product
    Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2021·2021-05-26

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets

    Preferred Pharmaceuticals is recalling specific lots of Metformin HCl Extended Release tablets due to the presence of NDMA impurity exceeding safety limits.

    Product
    Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0374-2021·2021-05-26

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.

    Product
    Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 194
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0384-2021·2021-05-26

    Pfizer Recalls Sterile Water Vials Due to Insect Particulate Matter

    Pfizer is recalling 49,525 vials of Sterile Water for Injection because an insect was found in one vial. The product is distributed nationwide.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2021·2021-05-26

    Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns

    Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.

    Product
    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V392000·2021-05-26

    Freightliner Recalls 2019 M2 Business Class Vehicles for Electrical Defect

    Daimler Trucks North America is recalling 2019 Freightliner M2 Business Class vehicles with 14Xe ePowertrains because insufficiently crimped stator wires may cause overheating and loss of drive power.

    Product
    FREIGHTLINER — FREIGHTLINER M2 BUSINESS CLASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2021·2021-05-26

    Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0381-2021·2021-05-26

    FDA Recalls PremierZen Extreme 3000 for Unapproved Tadalafil

    Hyobin LLC is recalling PremierZen Extreme 3000 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2021·2021-05-26

    Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns

    Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2021·2021-05-26

    Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns

    Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2021·2021-05-26

    Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V396000·2021-05-26

    2022 Thor Motor Coach RV models recalled for solar panel fire risk

    Thor Motor Coach is recalling certain 2022 Sequence, Rize, Scope, and Tellaro recreational vehicles. The Flex-190 solar panel junction box may experience electrical shorts, increasing the fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH SEQUENCE, TELLARO, RIZE, SCOPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0545-2021·2021-05-26

    Basic Grain Products Recalls Caramel Rice Cakes Due to Undeclared Milk

    Basic Grain Products Inc is recalling Caramel Rice Cakes sold under Kroger and Stop & Shop brands because the product contains undeclared milk.

    Product
    Caramel Rice Cakes 6.56oz (186g) 12 units per case 14 rice cakes per packaging Brands: Kroger Brand and Stop & Shop Brand
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1635-2021·2021-05-26

    Biopsybell Cement Mixing System Recalled for Potential Sterility Failure

    Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.

    Product
    CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide