The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

19376–19400 of 50410

  • HighFDA (Drugs)·D-0789-2021·2021-09-08

    China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination

    China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2021·2021-09-08

    Sushi Products Recalled Due to Salmonella in Frozen Shrimp

    Mai Cuisine is recalling sushi products sold at Genji Sushi counters in Northern California Whole Foods Markets due to Salmonella contamination in frozen shrimp used as an ingredient. Products with hand-crafted dates of 8/12/2021 or 8/13/2021 are affected.

    Product
    Sept Box of The Month (NCA) WR UPC: 84003140397 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0788-2021·2021-09-08

    China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination

    China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0790-2021·2021-09-08

    Topical Pain Relief AULIEF Recalled for Facility Contamination Risk

    China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.

    Product
    AULIEF — AULIEF (MENTHOL AND CAMOHOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0957-2021·2021-09-08

    Hostess Soft White Hamburger Buns Recalled for Listeria and Salmonella Risk

    Hostess Brands, LLC is recalling Hostess Soft White Hamburger Buns because the contract manufacturer detected positive environmental samples for Listeria and Salmonella species. The affected product was distributed to retailers and distributors across 34 states.

    Product
    Hostess Soft White Hamburger Buns, Net Wt. 12 OZ, UPC 888109110987
    Category
    Food
    Distribution
    35 states
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0953-2021·2021-09-08

    Mai Cuisine Cooked Variety Pack Recalled for Salmonella in Frozen Shrimp

    Mai Cuisine is recalling Cooked Variety Pack sushi products sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the products.

    Product
    COOKED VARIETY PACK UPC:81282401349 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2401-2021·2021-09-08

    Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device

    Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.

    Product
    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0939-2021·2021-09-08

    Shrimp California Roll recalled for Salmonella contamination

    Mai Cuisine is recalling Shrimp California Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Shrimp California Roll [WR] UPC: 81244803442 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0930-2021·2021-09-08

    Shrimp Tempura Kabuki Roll Recalled for Salmonella Contamination

    Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used in these products.

    Product
    12 PC Shrimp Tempura Kabuki Roll [BR] UPC: 81244803670 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0905-2021·2021-09-08

    Your Way Fresh Greek Yogurt Peach Parfait recalled for undeclared soy

    Your Way Fresh Greek Yogurt + Peach Parfait is being recalled because soy lecithin in an ingredient is not declared on the label, posing a risk to consumers with soy allergies.

    Product
    Your Way Fresh, Greek Yogurt + Peach Parfait; Net wt. 6.25 oz (177 g); UPC 8 54426 00809 2; Distributed by Your Way Fresh, Newport Beach, CA, 12 cups per case;
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2386-2021·2021-09-08

    Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling

    Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.

    Product
    STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2021·2021-09-08

    Norton Arm Kit surgical device recall due to sterilization failure

    Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.

    Product
    Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2406-2021·2021-09-08

    Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

    Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

    Product
    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0931-2021·2021-09-08

    Shrimp Tempura Kabuki Roll recalled for Salmonella contamination

    Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the products.

    Product
    12 PC Shrimp Tempura Kabuki Roll [WR UPC:81244803410 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0951-2021·2021-09-08

    Mai Cuisine Scorpion Roll Sushi Recalled for Salmonella

    Mai Cuisine is recalling Scorpion Roll sushi sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the product. The affected products were hand-crafted on 8/12/2021 and 8/13/2021.

    Product
    SCORPION ROLL UPC:81282401138 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2398-2021·2021-09-08

    Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error

    DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number…
    Category
    Medical Device
    Distribution
    10 states
  • HighNHTSA·21V693000·2021-09-07

    LDJ Recalls 2021 Thunder Creek Trailers Due to Fender Light Wiring Defect

    LDJ Manufacturing is recalling 279 2021 Thunder Creek trailers because improperly routed wiring may cause fender clearance lights to fail, increasing crash risk.

    Product
    THUNDER CREEK — THUNDER CREEK STT, MTO, SLT, MTT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E084000·2021-09-04

    Nineo F2-H11 LED Bulbs Recalled for Excessive Brightness

    Nineo is recalling F2-H11 replacement LED bulbs because they may be too bright, posing a glare hazard to oncoming drivers.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V691000·2021-09-03

    2021 Forest River Berkshire RVs Recalled for Electrical Fire Risk

    Forest River is recalling certain 2021 Berkshire recreational vehicles that may have unsealed mini-breakers in the electrical system, which could cause sparks and increase the risk of fire in the battery compartment.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V692000·2021-09-03

    2021-2022 Coachmen Nova motorhomes recalled for improper battery installation

    Forest River is recalling 2021-2022 Coachmen Nova motorhomes because the Absorbed Glass Mat battery was incorrectly installed, allowing hydrogen gas to accumulate inside the vehicle and create a risk of injury.

    Product
    COACHMEN — COACHMEN NOVA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V688000·2021-09-02

    Toyota Tundra vehicles recalled due to headlight electrical circuit fire risk

    Certain 2018-2021 Toyota Tundra vehicles have a headlight electrical circuit defect that may power high and low beams simultaneously, causing connector overheating and fire risk. Owners should contact Toyota or NHTSA for remedy information.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21778·2021-09-02

    Step2 StepUp Sidekick Learning Towers Recalled Due to Fall Hazard

    The Step2 Company is recalling StepUp Sidekick Learning Towers because the storage tray with cup holders and step can come loose, posing a fall hazard to children. Step2 has received 20 reports of the component coming loose, including one report of minor bruises from a fall.

    Product
    StepUp Sidekick Learning Towers
    Category
    Consumer Product
    Distribution
    Distributed nationwide