The Recall Desk

Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class ii recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

926–950 of 1428

  • HighFDA (Devices)·Z-2331-2025·2025-08-27

    Bayonet injection needles recalled after showing elevated cytotoxicity in testing

    Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.

    Product
    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0502-2025·2025-08-27

    Raw ramen noodles recalled because label omits soy as lecithin source

    Raw Ramen Noodle HA #22W in 10 lb bulk cases, made by Kobayashi Noodle USA, is recalled because the label does not declare soy as the source of the lecithin ingredient. 945 cases are affected.

    Product
    Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (16049) UPC: NONE Manufactured by: Kobayashi Noodle USA Allergens: Wheat, Egg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    Electrosurgical generators recalled over system error causing reboots during use

    The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Legacy electrosurgical generators recalled over system error triggering repeated device reboots

    The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2025·2025-08-27

    Deep brain stimulation burr hole kits recalled over retaining clip closing resistance

    Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.

    Product
    Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2025·2025-08-27

    Antiseptic towelettes recalled for lack of assurance of sterility

    BZK Antiseptic Towelettes containing benzalkonium chloride 0.13%, sold 100 per carton for professional use, are recalled for lack of assurance of sterility. The recall covers 3.85 million cartons.

    Product
    BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·H-0522-2025·2025-08-27

    Chick-fil-A biscuit mix recalled for undeclared eggs in bulk bags

    Biscuit Mix packed exclusively for Chick-fil-A, Inc. in 2.625 lb bags is recalled for undeclared eggs. The recall covers 150 cases of 12 bags.

    Product
    BISCUIT MIX, SNG 1000042143 NET WEIGHT 2.625 LBS Packed Exclusively For: Chick-fil-A, Inc. 5200 Buffington Road Atlanta, Ga 30349
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0504-2025·2025-08-27

    Zero sugar soda cans recalled because they contain full sugar product

    7up Zero Sugar Tropical Soda in 12 fl oz cans is recalled because the cans are labeled Zero Sugar but contain full sugar product. 1,954 cases are affected.

    Product
    7up Zero Sugar Tropical Soda, 12 FL OZ (355 mL) aluminum cans, packaged in 12 pack cardboard cartons labeled as 7up Tropical Flavored Soda, UPC (on can): 078000037975, UPC (on carton): 078000037982
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2329-2025·2025-08-27

    Endoscopy video processors recalled over hot light guide and thermal injury risk

    Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.

    Product
    Pentax Medical Video Processor; Model Number: EPK-i8020c;
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Drugs)·D-0591-2025·2025-08-27

    Sodium bicarbonate injection vials recalled for lack of assurance of sterility

    Hospira 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL, lot LH2671, is recalled nationwide for lack of assurance of sterility. 15,750 vials are affected.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2025·2025-08-27

    Estrone diagnostic kits recalled over rare falsely high or low results

    Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.

    Product
    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0503-2025·2025-08-27

    Bulk raw ramen noodles recalled because soy lecithin source is undeclared

    Raw Ramen Noodle HA #22W (4942) in 10 lb bulk cases, made by Kobayashi Noodle USA, is recalled because the label does not declare soy as the source of the lecithin ingredient. 2,800 cases are affected.

    Product
    Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (4942) UPC: NONE Manufactured by: Kobayashi Noodle USA Allergens: Wheat, Egg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0521-2025·2025-08-27

    Frozen half shell oysters from lot B250112 recalled over norovirus risk

    Imported Frozen Half Shell Oysters in 15-pound boxes, lot B250112, are recalled because they are potentially contaminated with norovirus. 98 cartons are affected.

    Product
    Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side panel reads: Method of harvest: Farm Raised Country of Origin: Republic of Korea
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0505-2025·2025-08-27

    Ojasvita Chocomalt 200 g pouches recalled for undeclared soy lecithin

    Sri Sri Tattva Ojasvita Chocomalt, 7 oz / 200 g paper pouches, is recalled because it contains undeclared soy lecithin. 1,100 units are affected.

    Product
    Sri Sri Tattva, Ojasvita Chocomalt,7oz / 200g, Paper Pouch, 25 packages per case
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-0590-2025·2025-08-27

    Epinephrine injection vials recalled for lack of assurance of sterility

    Hospira Epinephrine Injection USP, 1 mg/10 mL, lots LY3681, LY4360 and LY4416, is recalled nationwide for lack of assurance of sterility. 49,620 vials are affected.

    Product
    Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0520-2025·2025-08-27

    Frozen half shell oysters recalled over potential norovirus contamination

    Imported Frozen Half Shell Oysters in 15-pound boxes, lot B250123, are recalled because they are potentially contaminated with norovirus. 828 cartons are affected.

    Product
    Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side panel reads: Method of harvest: Farm Raised Country of Origin: Republic of Korea
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2344-2025·2025-08-27

    OtoLase starter kits recalled over potentially unsterilized product labeled as sterile

    OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.

    Product
    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0595-2025·2025-08-27

    Tavaborole topical solution recalled after discoloration found in one lot

    Tavaborole Topical Solution 5%, 10 mL bottles from lot T401968, distributed by Viona Pharmaceuticals, is recalled because of discoloration. 3,960 bottles are affected.

    Product
    TAVABOROLE — TAVABOROLE (TAVABOROLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2025·2025-08-27

    Suture retention devices recalled with no reason stated in FDA record

    DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.

    Product
    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2025·2025-08-27

    Strep A test kits recalled after shipment to unlicensed purchasing customers

    Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.

    Product
    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2335-2025·2025-08-27

    Calcium test slides recalled after calibration failures delayed patient results

    VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.

    Product
    VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2345-2025·2025-08-27

    ELISA sample tip racks recalled over internal label misidentifying tip type

    Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.

    Product
    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2296-2025·2025-08-20

    Custom waste management kit tubing may trap air in the line

    Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.

    Product
    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2025·2025-08-20

    Quallent duloxetine 60 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states