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

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

3676–3700 of 39824

  • CriticalFDA (Devices)·Z-1946-2025·2025-06-25

    Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

    Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

    Product
    Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1943-2025·2025-06-25

    Dexcom G6 Glucose Receiver recalled for missed audible alerts

    Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.

    Product
    Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2025·2025-06-25

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.

    Product
    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1992-2025·2025-06-25

    Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks

    Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.

    Product
    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2025·2025-06-25

    Biomet 3i Certain-Compatible 4.1mm Milled Titanium Dental Abutments

    Preat Corp is recalling Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model 9001767-F) due to manufacturing defects that may cause improper screw engagement. The screw seat was positioned too high, potentially compromising the attachment of mating screws to the underlying implant.

    Product
    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2025·2025-06-25

    UROSKOP Omnia X-ray System Model 10094910 Frequency Inverter Overheating Recall

    Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.

    Product
    UROSKOP Omnia. Model Number: 10094910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2025·2025-06-25

    Fitbone Trochanteric Nail may bend during insertion and require replacement

    Orthofix Srl is recalling Fitbone Trochanteric Nails (Lot B4771336 and B4771337) because the implant may bend at the distal tail during insertion, potentially requiring replacement.

    Product
    REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1990-2025·2025-06-25

    ICU Medical Plum Duo Infusion Pump Software Dose Limit Issue

    ICU Medical is recalling Plum Duo infusion pumps with software version 1.1.1 because a workflow may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses to be programmed.

    Product
    ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1988-2025·2025-06-25

    Optima Coil System embolization coils recalled for defective radiopaque marker

    BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was not manufactured to specification.

    Product
    Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2025·2025-06-25

    ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

    ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

    Product
    ICU Medical Plum Solos, Item number 400011001; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2025·2025-06-25

    Siemens UROSKOP Omnia Max frequency inverter fire risk recalled

    Siemens is recalling UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.

    Product
    UROSKOP Omnia Max. Model Number: 10762473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2025·2025-06-25

    Portable Oxygen Concentrator with Erroneous Calibration Values

    Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.

    Product
    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2025·2025-06-25

    Prestige Coil System implantable devices recalled for manufacturing defect

    BALT USA is recalling Prestige Coil System implantable embolization devices because radiopaque markers on some units were not manufactured to specification and were not visible during angiography.

    Product
    Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 0081006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1986-2025·2025-06-25

    Surgical Mesh Recalled Due to Residual Adhesive Material Concern

    Chamberlain Technologies LLC is recalling SURGIMESH WN polymeric surgical mesh due to potential residual adhesive material on the mesh surface. The recall affects 20 units distributed to Illinois, Nebraska, and California.

    Product
    SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1979-2025·2025-06-25

    Pluslife SARS-CoV-2 Card Test Kits Recalled for Lack of FDA Authorization

    Pluslife SARS-CoV-2 Card nucleic acid testing kits were distributed in the U.S. without required FDA premarket authorization. The FDA is recalling approximately 1,850 boxes distributed nationwide and internationally.

    Product
    Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2025·2025-06-25

    Surgical Mesh Product Recalled Due to Residual Adhesive Material

    Chamberlain Technologies is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The product was distributed to facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1941-2025·2025-06-25

    Lago X X-ray instrument recall due to labeling discrepancies

    Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA requirements.

    Product
    Lago X
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1983-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH WN Polymeric Surgical Mesh due to potential residual adhesive material on the mesh surface. The 60-unit recall affects medical facilities in Illinois, Nebraska, and California.

    Product
    SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1978-2025·2025-06-25

    MiniDock Integrated Nucleic Acid Testing Device Recall

    Guangzhou Pluslife Biotech is recalling the MiniDock Integrated Nucleic Acid Testing Device (Model PM001) because it was distributed in the U.S. without required FDA premarket authorization.

    Product
    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2025·2025-06-25

    STA-Owren Koller Buffer Solution Recall Due to Clotting Time Concerns

    Diagnostica Stago is recalling STA-Owren Koller buffer solution (Lot 270902) because it may produce shorter clotting times in certain tests, potentially leading to a 1% overestimate of clotting results.

    Product
    STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1976-2025·2025-06-25

    AcoSound LW12-BTE-M Hearing Aid Labeling and UDI Information Errors

    Hangzhou AcoSound Technology Co., Ltd. is recalling 120 units of the AcoSound Model LW12-BTE-M hearing aid due to labeling errors, including incorrect manufacturer attribution, missing manufacturer business address, and incomplete UDI information.

    Product
    AcoSound. Model Number: LW12-BTE-M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1929-2025·2025-06-18

    Philips Intera 1.5T Achieva IT Nova MRI System Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, or death.

    Product
    Intera 1.5T Achieva IT Nova Product Number: 781175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide