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.

6951–6975 of 29119

  • SevereFDA (Devices)·Z-0628-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use

    Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.

    Product
    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2022·2022-02-23

    Paragard T380A Intrauterine Contraceptive Device Recall for Non-Sterility

    CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.

    Product
    PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0630-2022·2022-02-23

    THE RED PILL EXTRA STRENGTH Capsules Recalled for Undeclared Tadalafil

    THE RED PILL EXTRA STRENGTH 800 mg capsules are being recalled because they contain undeclared tadalafil, an active ingredient in FDA-approved sexual-enhancement medications. The product was marketed and distributed as an unapproved drug nationwide via Amazon.

    Product
    THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0562-2022·2022-02-23

    MAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients

    MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.

    Product
    MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0623-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled

    Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0568-2022·2022-02-23

    RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance

    BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.

    Product
    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation

    Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V104000·2022-02-23

    Tesla Model S Side Curtain Air Bag Inflator Defect

    Tesla is recalling 2021-2022 Model S vehicles due to side curtain air bag inflators that may have been assembled incorrectly. This could cause delayed air bag deployment during a crash, increasing injury risk.

    Product
    TESLA — TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0624-2022·2022-02-23

    Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation

    Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0625-2022·2022-02-23

    Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use

    Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0633-2022·2022-02-23

    HYDROmorphone HCl syringe recalled due to labeling mix-up

    STAQ Pharma is recalling HYDROmorphone HCl PF syringes (lot 21104221A) that were incorrectly labeled as Morphine Sulfate PF. The mislabeling affects approximately 905 syringes distributed in Colorado, Ohio, and Texas.

    Product
    HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0638-2022·2022-02-23

    RED MAMMOTH 400 mg Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    RED MAMMOTH capsules, 400 mg (Lot # DK1027, Exp. 08/01/2023) are being recalled because they contain undeclared sildenafil and tadalafil, making them an unapproved drug marketed without FDA authorization.

    Product
    RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0738-2022·2022-02-23

    Xuerong Brand Enoki Mushrooms Recalled for Listeria Contamination

    Golden Medal Mushroom Inc is recalling Xuerong brand enoki mushrooms because Listeria monocytogenes was detected in the product. The affected product was distributed in Illinois.

    Product
    Enoki Mushrooms, brand Xuerong, net wt. 200g/7.05-ounce packages, UPC 6 953150 100684. Product sent to distributor is packaged in a brown cardboard master case. The product name "ENOKI MUSHROOM" and other information in Chinese are printed in green color. The code "30051
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0622-2022·2022-02-23

    Vyaire Medical Ventilators Recalled Due to Potential Ventilation Failure

    Vyaire Medical is recalling 4,189 bellavista 1000 and 1000e ventilators worldwide due to potential cessation of ventilation under specific conditions. This FDA Class I recall poses serious risk to patients who depend on these critical care devices.

    Product
    bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0563-2022·2022-02-23

    MAC DADDY PURPLE Capsules Recalled for Undeclared Drug Ingredients

    ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.

    Product
    MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0631-2022·2022-02-23

    365 SKINNY High Intensity Capsules Recalled for Undeclared Sibutramine

    Je Dois Lavoir LLC is recalling 365 SKINNY High Intensity Capsules (600 mg, 30-count bottles) because the product contains undeclared sibutramine, a drug previously withdrawn from the US market due to safety concerns.

    Product
    365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0629-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall

    Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.

    Product
    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0634-2022·2022-02-23

    Morphine Sulfate Syringe Recall Due to Labeling Mix-Up

    STAQ Pharma is recalling a limited number of syringes labeled as Morphine Sulfate PF that actually contain HYDROmorphone HCl PF due to a labeling error. The affected lot was distributed to Colorado, Ohio, and Texas.

    Product
    Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·22V100000·2022-02-22

    2021 Porsche Taycan: Center Seat Belt Buckle May Block Child Seat Anchors

    Porsche is recalling 2020-2021 Taycan vehicles with optional rear center seats. The center seat belt buckle wiring harness may obstruct access to child seat anchors, preventing proper installation.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V098000·2022-02-18

    Mercedes-Benz Recalls 2020 GLE 350 for Wiring Harness Defect

    Mercedes-Benz is recalling 2020 GLE 350 vehicles because an unsecured wiring harness may disable power steering, headlights, or wipers, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V096000·2022-02-18

    Kia Recalls 2014 Soul Vehicles Due to Air Bag Software Defect

    Kia is recalling 2014 Soul vehicles because the front air bags may not deploy in a crash if the control unit loses communication with sensors.

    Product
    KIA — KIA SOUL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2022·2022-02-18

    Corfu Foods Recalls Swai Fillets Imported Without Reinspection

    Corfu Foods is recalling 6,570 pounds of frozen swai fillets imported from Vietnam without required reinspection. No illnesses have been reported.

    Product
    Corfu Foods, Inc. Recalls Swai (Siluriformes) Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·22V093000·2022-02-17

    Kia Recalls 2013-2014 Optima Vehicles for Fuel Hose Fire Risk

    Kia is recalling 2013-2014 Optima vehicles previously repaired under recall 20V-100 because a damaged or missing heat-protective tape on the low-pressure fuel hose can cause a fuel leak and increase fire risk.

    Product
    KIA — KIA OPTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V091000·2022-02-17

    2022 Chevrolet Corvette rear driveshaft defect may cause loss of power

    General Motors is recalling 2021-2022 Chevrolet Corvette vehicles whose rear half-shaft assemblies may be missing ball bearings. This can cause sudden loss of drive power, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide