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.

11101–11125 of 53043

  • HighFDA (Devices)·Z-0227-2024·2023-11-15

    Medical imaging systems recalled for missing safety spacer and warning label

    Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.

    Product
    Integris-Allura IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0288-2024·2023-11-15

    EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures

    Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.

    Product
    EVIS EXERA III Gastrointestinal Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2024·2023-11-15

    Prescription Drug Recalled Due to Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.

    Product
    EXTENDED PHENYTOIN SODIUM — EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2024·2023-11-15

    Monitron II Waveform Analyzer Screen Freeze Defect in Ventilator Models

    Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.

    Product
    Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0282-2024·2023-11-15

    Orthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up

    Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.

    Product
    RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0230-2024·2023-11-15

    Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers

    Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.

    Product
    Veradius Unity Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0226-2024·2023-11-15

    Surgical C-arm systems recalled for missing warning label and spacer

    Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.

    Product
    Zenition 50 & 70 Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0328-2024·2023-11-15

    Infant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive

    Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.

    Product
    Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-0283-2024·2023-11-15

    Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images

    Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.

    Product
    Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0264-2024·2023-11-15

    Family Dollar Pregnancy Test Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0228-2024·2023-11-15

    X-ray imaging systems recalled for missing warning label and spacer

    Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.

    Product
    Allura Xper IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0272-2024·2023-11-15

    DigitalDiagnost 4 Ceiling-Mounted X-Ray Units Recall for Fall Hazard

    Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.

    Product
    DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2024·2023-11-15

    SA3000 intravenous adapters recalled for manufacturing defect causing leakage

    B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.

    Product
    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0321-2024·2023-11-15

    Greenhead Lobster Products Recalls Frozen and Fresh Lobster Meat for Listeria

    Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.

    Product
    Frozen and fresh RTE Lobster meat (1 lb. packages to 12 lb. case) 1. Greenhead Lobster HPP Fresh Cooked Claw and Knuckle Meat GHL-CKF - Fresh - 1 lb. oxygen permeable bag, master cased in a 12 lbs. Styrofoam box 2. Greenhead Lobster Fresh Cooked Claw and Knuckle Meat GHL-CKF…
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0372-2024·2023-11-15

    Diced Yellow Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions, LLC is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The 1,940-pound recall affects products distributed in the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0290-2024·2023-11-15

    Medical device blood oxygenation system recalled due to defective weld

    Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.

    Product
    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2024·2023-11-15

    Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling

    AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • HighNHTSA·23V763000·2023-11-11

    Nova Bus LFS Transit Buses Recalled for HVAC Unit Bracket Failure

    Nova Bus (US) Inc. is recalling 2020–2023 LFS transit buses because mounting brackets for the HVAC unit could fail, causing the unit to detach and create a road hazard. Free repairs are available through Nova Bus customer service.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V762000·2023-11-11

    2022 Nova Bus LFS Transit Buses Recalled for Turn Signal Failure

    Nova Bus is recalling certain 2021-2023 LFS transit buses due to defective turn signal wiring that may fail intermittently, increasing crash risk. Free repairs are available.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V761000·2023-11-10

    Prevost Motor Coaches Recalled for Fire Risk in Grid Heater System

    Prevost Car (US) Inc. is recalling 204 certain 2023-2024 H3-45 and X3-45 VIP motor coaches due to loose grid heater cable connections that can cause the relay to overheat, increasing fire risk.

    Product
    PREVOST — PREVOST X3-45, H3-45 VIP, X3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·058-2023·2023-11-10

    JX Restaurant Recalls Chicken Products Due to Undeclared Sesame Oil

    JX Restaurant, Inc. is recalling fully-cooked chicken products because they contain sesame oil, a known allergen, that is not declared on the label.

    Product
    JX Restaurant, Inc. Recalls Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V759000·2023-11-10

    Solar Panels May Detach from Thor Rize and Scope Motorhomes

    Thor Motor Coach is recalling 2021-2024 Rize and Scope motorhomes because the solar panel frame may fracture at the mounting bolts and detach, creating a road hazard.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH SCOPE, RIZE, redundant RIZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V752000·2023-11-09

    Jayco Recalls 2023-2024 White Hawk Travel Trailers Due to Window Labeling

    Jayco is recalling 2023-2024 White Hawk travel trailers because a window may be incorrectly marked as an emergency exit, potentially delaying evacuation.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide