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.

11001–11025 of 53043

  • HighFDA (Drugs)·D-0106-2024·2023-11-22

    Compressed Oxygen Cylinders Recalled Due to Manufacturing Quality Deviations

    Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.

    Product
    Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2024·2023-11-22

    Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning

    Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.

    Product
    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2024·2023-11-22

    Atrium Advanta V12 Covered Stent System Recalled for Weld Failure

    Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.

    Product
    Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0305-2024·2023-11-22

    Defibrillator battery pins may loosen, affecting power

    Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2024·2023-11-22

    Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning

    A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.

    Product
    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0417-2024·2023-11-22

    Hemp Oil Gummies Recalled Due to Undeclared Sunflower Butter Allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because sunflower butter sub-ingredients were not declared on the label. Consumers with sunflower allergies may experience allergic reactions.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0416-2024·2023-11-22

    Hemp Oil Gummies Recalled for Undeclared Sunflower Butter Sub-Ingredients

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because the sub-ingredients of sunflower butter were not declared on the label. The affected packages were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Peach, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0315-2024·2023-11-22

    Cardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions

    ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.

    Product
    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0296-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening

    Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.

    Product
    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24717·2023-11-22

    MI Windows and Doors Vinyl Sliding Glass Doors Serious Injury Hazard Recall

    MI Windows and Doors is recalling about 1,900 vinyl sliding glass doors because the glass can separate from the frame during hurricane conditions, posing a serious injury hazard. No injuries have been reported.

    Product
    MI 1615 and 1617 Sliding Glass Doors; Window World 4000 Series and 8000 Series Sliding Glass Doors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0418-2024·2023-11-22

    Hemp Oil Gummies Recalled for Undeclared Sunflower Butter Sub-ingredients

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel in 1.41 oz and 8 oz packages due to undeclared sub-ingredients in the sunflower butter component. Consumers should not consume the affected product.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·23V791000·2023-11-22

    2021 Nissan Rogue rear brake calipers may leak fluid

    Certain 2021 Nissan Rogue vehicles may have missing internal bushings in rear brake calipers, allowing brake fluid to leak and reduce braking performance.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V788000·2023-11-22

    Grand Design Reflection Travel Trailers Recalled Due to Electrical Fire Hazard

    Grand Design is recalling 2024 Reflection travel trailers with reversed electrical receptacles that can fail and increase fire risk. Owners should contact dealers for free replacement.

    Product
    GRAND DESIGN — GRAND DESIGN REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24716·2023-11-22

    PandaEar Stainless Steel Toddler Cups Recalled for Excessive Lead Content

    PandaEar Stainless Steel Toddler Cups are being recalled because their exterior solder contains lead levels that exceed federal limits. About 1,600 cups sold on Amazon from May through August 2023 are affected. No injuries have been reported.

    Product
    PandaEar Stainless Steel Toddler Cups, 8 oz.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2024·2023-11-22

    Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations

    Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V794000·2023-11-22

    Lode King Prestige Semi-Trailers Recalled for Chute Door Defect

    Lode-King is recalling 2021-2024 Prestige semi-trailers because an unlocked chute door may fall off while in transit, creating a road hazard.

    Product
    LODE KING — LODE KING PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2024·2023-11-22

    DOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico

    Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.

    Product
    DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·23V784000·2023-11-21

    2024 Big Tex Trailers Recalled for Defective Goodride Tires

    Big Tex Trailer Manufacturing is recalling certain 2024 trailers equipped with defective Goodride ST 200 tires. The tire sidewalls may bubble and separate, causing pressure loss and increasing crash risk.

    Product
    BIG TEX — BIG TEX 14FT, TT14, 70ST, 25PH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V782000·2023-11-21

    2023 Honda HR-V Seat Belt Pretensioner Assembly May Fail to Restrain

    Honda is recalling certain 2023-2024 HR-V vehicles because the front seat belt pretensioners may be missing a rivet, which could cause the restraint to fail during a crash.

    Product
    HONDA — HONDA ACCORD, HR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V781000·2023-11-21

    2023 Nova Bus Transit Buses Recalled for Detachable Sun Visor Risk

    Nova Bus is recalling certain 2023 LFS transit buses because the sun visor may detach from its bracket. A loose sun visor could distract the driver or block the windshield view, increasing crash risk.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V783000·2023-11-21

    2022-2023 Rivian R1T and R1S Defroster Defogger Software Failure Recall

    A software update may have deactivated the defroster and defogger on certain 2022-2023 Rivian R1T and R1S vehicles, reducing visibility and increasing crash risk. Rivian will release a free over-the-air software update.

    Product
    RIVIAN — RIVIAN R1S, R1T
    Category
    Vehicle
    Distribution
    Distributed nationwide