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.

3876–3900 of 4878

  • 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
  • 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 (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
  • 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 (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-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 (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 (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-0627-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device catheter tips may separate during use

    The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters due to reports of tip separation during use. Approximately 3,668 units were distributed worldwide.

    Product
    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native a
    Category
    Medical Device
    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 (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 (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-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-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 (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 (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 (Food)·F-0649-2022·2022-02-16

    Arugula Products Recalled for Potential Listeria Monocytogenes Contamination

    Multiple brands of 5oz bagged arugula are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed to consumers across multiple states.

    Product
    Ahold 5oz Arugula Product UPC 688267011559 Dole 5oz Arugula Product UPC 071430010723 Kroger 5oz Organic Baby Arugula Clamshell Product UPC 111110911506 Lidl 5oz Baby Arugula Product UPC 4056489210535 Marketside 5oz Organic Arugula Clamshell Product UPC 681131221733 Natu
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0720-2022·2022-02-16

    Dr. Snack Goji Berry recalled for undeclared sulfites

    Dr. Snack Goji Berry products contain undeclared sulfites. Sulfite-sensitive consumers may experience allergic reactions.

    Product
    Dr. Snack Goji Berry; PACKED FOR B.C.S. INTERNATIONAL CORP; 4.5oz, 6oz, 9oz packs clear plastic packs and 5lb cardboard boxes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0673-2022·2022-02-16

    Dole BBQ Ranch Chopped Kit Recalled for Potential Listeria Contamination

    Dole is recalling 13 oz BBQ Ranch Chopped Kits due to potential Listeria monocytogenes contamination. Affected products have 'N' or 'Y' code prefixes with Best If Used By dates between November 30, 2021 and January 8, 2022.

    Product
    Dole 13 oz BBQ Ranch Chopped Kit Product UPC 071430000298
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0659-2022·2022-02-16

    Caesar salad kits recalled for potential Listeria monocytogenes contamination

    Caesar salad kits from multiple brands are being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed across 40 states with code dates between November 30, 2021 and January 8, 2022.

    Product
    Dole 10oz Caesar Kit Product UPC 071430008065 Lidl 10oz Caesar Kit Product UPC 20737740 Little Salad Bar 10.65oz Caesar Kit Product UPC 4099100263923 Little Salad Bar 10oz Caesar Kit Product UPC 4099100087000 Dole 11.3oz Ultimate Caesar Kit Product UPC 071430017029 Mark
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Drugs)·D-0561-2022·2022-02-16

    HARD DAWN Rise and Shine Capsules Recalled for Undisclosed Tadalafil

    HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved drug, without proper approval or labeling. The product was sold nationwide via Amazon.

    Product
    HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0655-2022·2022-02-16

    Dole Chopped Greek Salad Recalled for Potential Listeria Contamination

    Dole is recalling 10.6oz Chopped Greek Salad products due to potential Listeria monocytogenes contamination. The affected products were distributed across 38 U.S. states.

    Product
    Dole 10.6oz Chopped Greek Product UPC 071430000885
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0669-2022·2022-02-16

    Dole Chopped Salad Kits Recalled for Potential Listeria Contamination

    Dole and Little Salad Bar chopped salad kits with specific date codes are being recalled due to potential Listeria monocytogenes contamination. Consumers should not eat the affected products.

    Product
    Dole 12.2oz Chopped Sunflower Crunch Kit Product UPC 071430000342 Little Salad Bar 12oz Chop Sunflower Crunch Kit Product UPC 4099100087925
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0650-2022·2022-02-16

    Multiple Brands Spring Mix Recalled for Potential Listeria Contamination

    Spring mix products sold under multiple brand and retailer names are being recalled due to potential Listeria monocytogenes contamination. The recall affects spring mix distributed across the United States.

    Product
    Ahold 5oz Spring Mix Product UPC 688267011191 Dole 5oz Organic Spring Mix Clamshell Product UPC 071430846254 Kroger 10oz Spring Mix Clamshell Product UPC 011110910523 Dole 5oz Spring Mix Product UPC 071430009437 Kroger 16oz Organic Spring Mix Clamshell Product UPC 111110
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-0717-2022·2022-02-16

    Natures Promise Organic Baby Spring Mix Recalled for Potential Listeria

    Dole Fresh Vegetables Inc is recalling Natures Promise 5oz Organic Baby Spring Mix Clamshell due to potential Listeria monocytogenes contamination. Affected products bear codes beginning with 'N' or 'Y' with Best if Used By dates from November 30, 2021 through January 8, 2022.

    Product
    Natures Promise 5oz Organic Baby Spring Mix Clamshell Product UPC 688267154546
    Category
    Food
    Distribution
    36 states