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.

1201–1225 of 4878

  • SevereFDA (Devices)·Z-1048-2024·2024-02-28

    Dover Foley catheter convenience kits recalled due to component defects

    Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, D
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1047-2024·2024-02-28

    Dover Foley catheters recalled due to defective supplied components

    Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by Nurse Assist.

    Product
    Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0343-2024·2024-02-28

    Herbal dietary supplement recalled for undeclared drug ingredient

    Sustain Herbal Dietary Supplement is being recalled nationwide for containing undeclared tadalafil, a pharmaceutical ingredient. The product was marketed as a dietary supplement but contains an unapproved drug.

    Product
    Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2024·2024-02-28

    SCHWINNNG Herbal Dietary Supplement Recalled for Undeclared Nortadalafil Content

    SCHWINNNG Herbal Dietary Supplement (Lot #2108, exp. 10/31/2024) is recalled nationwide because it contains undeclared nortadalafil, an active pharmaceutical ingredient used for male sexual enhancement. The FDA classified this as an unapproved drug.

    Product
    SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1043-2024·2024-02-28

    Argyle Suction Catheter Trays with Chimney Valve recalled for defective components

    Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.

    Product
    Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Cathet
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1082-2024·2024-02-28

    Medical Closure Kit Recall: Sterility of Saline Cannot Be Guaranteed

    Windstone Medical Packaging is recalling Aligned Medical Solutions Closure Kits due to inability to guarantee sterility of included saline. This FDA Class I recall affects 475 units distributed in Florida, Illinois, and California.

    Product
    Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1045-2024·2024-02-28

    Dover Foley Catheter and Urinary Drainage Kits Recalled for Defective Components

    Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILL
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0910-2024·2024-02-28

    Ham and Cotija Torta Sandwiches Recalled for Listeria Contamination

    Compass Group USA, Inc. is recalling 206 Ham & Cotija Torta Sandwiches due to Listeria monocytogenes contamination in Cotija cheese. Products were distributed in Florida with use-by dates of February 9-16, 2024.

    Product
    Ham & Cotija Torta Sandwich on Telera Roll, 8.3 oz, plastic container, UPC 100001002017
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1052-2024·2024-02-28

    Dover Foley Catheter Kits and Drain Trays Recalled

    Dover Foley catheter kits and silicone drain trays manufactured with subsequently recalled components were distributed to 924 units across the US, EMEA, Japan, and Latin America.

    Product
    Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0346-2024·2024-02-28

    TING Athlete's Foot Spray Recalled Due to Benzene Contamination

    Insight Pharmaceuticals is recalling TING 1% Tolnaftate Athlete's Foot Spray due to benzene contamination. The recall affects approximately 59,644 cans distributed nationwide.

    Product
    TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1051-2024·2024-02-28

    Cardinal Health Foley Catheter Kits Recalled Over Supplier Component Defect

    Cardinal Health is recalling 36,300 Foley urinary drainage convenience kits due to components that were subsequently recalled by supplier Nurse Assist.

    Product
    Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1001-2024·2024-02-28

    Baxter Exactamix Pro 1200 Software Error Causes Medication Over-delivery

    Baxter Healthcare is recalling the Baxter Exactamix Pro 1200 medication compounding device due to a software error that may cause ingredient over-delivery when using the 'Use Some Overfill' feature.

    Product
    Baxter Exactamix Pro 1200, REF EXM12DY
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Food)·F-0909-2024·2024-02-28

    Hale and Hearty Tomato Basil and Rice Soup Recalled for Undeclared Soy

    Hale and Hearty Soups is recalling Tomato Basil and Rice soup (UPC 635508547872) due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Hale and Hearty Soups; Tomato Basil and Rice; UPC 635508547872
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1080-2024·2024-02-28

    Surgical ocular packs recalled for loss of saline sterility

    Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.

    Product
    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1079-2024·2024-02-28

    Surgical Kit with Saline Recalled Over Sterility Assurance Issue

    Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.

    Product
    Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1044-2024·2024-02-28

    Tracheostomy Supply Kits Recalled for Defective Components

    Cardinal Health is recalling 661,560 tracheostomy kits because they were manufactured with components that were subsequently recalled by another manufacturer.

    Product
    TRACH KIT W/HYDROGEN & SALI
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0334-2024·2024-02-28

    Drug Recalled for Marketing Unapproved Tianeptine Without FDA Approval

    Neptune's Fix Tianeptine Elixir is recalled nationwide for containing tianeptine, an FDA-unapproved substance. The product was marketed without required FDA approval.

    Product
    Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2024·2024-02-28

    Neptune's Fix Tianeptine Tablets Recalled for FDA Unapproved Marketing

    Neptune's Fix Tianeptine Tablets are being recalled because the product contains tianeptine, a substance not approved by the FDA for any medical use. The recall affects 4,932 boxes distributed nationwide.

    Product
    Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1050-2024·2024-02-28

    Dover Foley Catheter Kits Recalled Due to Defective Components

    Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.

    Product
    Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML D
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0333-2024·2024-02-28

    FDA Recalls Neptune's Fix Tianeptine Elixir for Containing Unapproved Drug

    Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.

    Product
    Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2024·2024-02-28

    Dietary supplement Arize recalled for undeclared pharmaceutical ingredient

    Arize Herbal Dietary Supplement contains an undeclared ingredient (nortadalafil), a pharmaceutical used in FDA-approved male sexual enhancement medications, making it an unapproved drug.

    Product
    Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1049-2024·2024-02-28

    Dover Irrigation Convenience Kits Recalled for Component Defects

    Cardinal Health is recalling Dover Irrigation convenience kits that contained components which were separately recalled. The recall affects over 63,000 units distributed across the US, EMEA, Japan, and Latin America.

    Product
    Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
    Category
    Medical Device
    Distribution
    0 states
  • SevereCPSC·24129·2024-02-22

    Machir Biometric Personal Safes Recalled Due to Lock Failure Risk

    Machir LLC recalled about 24,820 biometric personal safes because the biometric lock can fail and allow unauthorized access. The firm received 15 reports of the lock failing to secure safes, posing a serious injury hazard and risk of death if firearms are stored inside.

    Product
    Machir Biometric Personal Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24128·2024-02-22

    MouTec Biometric Firearm Safes Recalled for Unauthorized Access Risk

    The CPSC is recalling about 2,200 MouTec brand biometric firearm safes because the biometric lock can be opened by unauthorized users, posing a serious injury hazard and risk of death. One incident involved a 6-year-old opening the safe, though no injuries have been reported.

    Product
    MouTec brand Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide