The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

Agency

Category

Minimum severity

Clear filters

1576–1600 of 27375

  • HighFDA (Devices)·Z-0866-2026·2025-12-10

    IntelliVue MX600 patient monitors recalled because an alarm may not sound

    Philips North America is recalling the IntelliVue Patient Monitor MX600 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue Patient Monitor MX600. Product Number: 865242.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2026·2025-12-10

    DNA sequencing reagent kits recalled over flow cell gasket leaks

    Illumina is recalling 11,916 NextSeq 550Dx reagent kits because flow cell gaskets have a quality issue that may cause leaks during runs, including possible toxic substance exposure to the user.

    Product
    Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 2002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2026·2025-12-10

    Clotting time test cuvettes recalled over a sharp-edged foreign object

    Accriva Diagnostics is recalling 20,250 Hemochron Activated Clotting Time Low-Range test cuvettes because a foreign object with sharp edges may pose a risk of injury if not detected before handling.

    Product
    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2026·2025-12-10

    Fecal immunochemical tests recalled over the potential for false negative results

    Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits after the test failed sensitivity testing with one test card lot, which may result in false negative results.

    Product
    InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2026·2025-12-10

    IntelliVue X2 measurement servers recalled over a potential failure to alarm

    Philips North America is recalling the IntelliVue Multi Measurement Server X2 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue Multi Measurement Server X2. Product Number: M3002A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2026·2025-12-10

    Fibula nails recalled over out of specification thread depths on the implant

    Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.

    Product
    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0531-2026·2025-12-03

    Pericardial patches recalled because a lot may not meet tensile strength

    Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0532-2026·2025-12-03

    Smaller pericardial patches recalled over a tensile strength specification failure

    Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0570-2026·2025-12-03

    Ligating devices recalled because the loop may not release as expected

    Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.

    Product
    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0579-2026·2025-12-03

    Duodenoscopes recalled after continued reports of positive cultures and infections

    Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.

    Product
    Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2026·2025-12-03

    IV set 490193 recalled over backflow and inability to prime

    B. Braun Medical is recalling 111,312 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR HF 4-WAY
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0634-2026·2025-12-03

    Extension sets recalled over piggyback backflow into primary containers

    B. Braun Medical is recalling 23,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2026·2025-12-03

    IV set 470005 recalled over medication backflow and priming failure

    B. Braun Medical is recalling 29,900 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0689-2026·2025-12-03

    Secondary IV sets recalled over backflow into the primary container

    B. Braun Medical is recalling 25,728 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, QUAD MANIFOLD
    Category
    Medical Device
    Distribution
    0 states