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.

5251–5275 of 22041

  • HighFDA (Devices)·Z-2372-2025·2025-09-03

    [pending] L12-3 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2372-2025.

    Product
    L12-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2025·2025-09-03

    [pending] L8-4 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2381-2025.

    Product
    L8-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2025·2025-09-03

    [pending] X7-2t Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2412-2025.

    Product
    X7-2t Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2025·2025-09-03

    [pending] L12-4 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2373-2025.

    Product
    L12-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2025·2025-09-03

    [pending] STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended

    Pending LLM rewrite. Source: FDA_DEVICE Z-2475-2025.

    Product
    STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2025·2025-09-03

    [pending] V9-2 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2404-2025.

    Product
    V9-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2025·2025-09-03

    [pending] Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Produc

    Pending LLM rewrite. Source: FDA_DEVICE Z-2416-2025.

    Product
    Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0530-2025·2025-09-03

    [pending] 1) Middlefield Original Cheese Co-op Monterey Jack Cheese, 8 oz. individual units, 5 lb. loaves, and

    Pending LLM rewrite. Source: FDA_FOOD H-0530-2025.

    Product
    1) Middlefield Original Cheese Co-op Monterey Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic 2) Middlefield Original Cheese Co-op Farmers Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0598-2025·2025-09-03

    [pending] SUCRALFATE (SUCRALFATE)

    Pending LLM rewrite. Source: FDA_DRUG D-0598-2025.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2025·2025-09-03

    [pending] S9-2 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2399-2025.

    Product
    S9-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2025·2025-09-03

    [pending] C9-3v Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2362-2025.

    Product
    C9-3v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2453-2025·2025-09-03

    [pending] BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD P

    Pending LLM rewrite. Source: FDA_DEVICE Z-2453-2025.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2025·2025-09-03

    [pending] S4-1 Lumify Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2392-2025.

    Product
    S4-1 Lumify Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2025·2025-09-03

    [pending] mC7-2 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2384-2025.

    Product
    mC7-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2025·2025-09-03

    [pending] S8-3 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2397-2025.

    Product
    S8-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V218000·2025-09-03

    [pending] 2023 JAYCO SOLSTICE

    Pending LLM rewrite. Source: NHTSA 24V218000.

    Product
    JAYCO — 2023 JAYCO SOLSTICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2025·2025-09-03

    [pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK -

    Pending LLM rewrite. Source: FDA_DEVICE Z-2467-2025.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2466-2025·2025-09-03

    [pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Numb

    Pending LLM rewrite. Source: FDA_DEVICE Z-2466-2025.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0596-2025·2025-09-03

    [pending] ACETAMINOPHEN (ACETAMINOPHEN)

    Pending LLM rewrite. Source: FDA_DRUG D-0596-2025.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2025·2025-09-03

    [pending] X3-1 Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2407-2025.

    Product
    X3-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2025·2025-09-03

    [pending] Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS

    Pending LLM rewrite. Source: FDA_DEVICE Z-2343-2025.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2025·2025-09-03

    [pending] D5cwc Transducer Probe

    Pending LLM rewrite. Source: FDA_DEVICE Z-2368-2025.

    Product
    D5cwc Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide