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.

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2826–2850 of 13446

  • HighFDA (Devices)·Z-2094-2025·2025-07-16

    Dental resin cartridges recalled for expiration date formatting error

    Stratasys recalled approximately 109 units of TrueDent White dental resin cartridges due to an expiration date formatting error. The error prevents system detection of expired material, creating risk that expired resin could be unknowingly used in dental appliances.

    Product
    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak Surgical Packs Recalled for Potential Sterility Compromise

    Alcon Custom Pak sterile surgical procedure packs are being recalled because some units may have damage to the packaging's lid area, which could compromise sterility. No illnesses have been reported.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    Cardiac device recall due to potential sterile barrier compromise

    Boston Scientific is recalling the VersaCross RF Wire cardiac device due to potential holes in the sterile barrier pouch. These defects could compromise device sterility and potentially lead to systemic infection or sepsis.

    Product
    VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2025·2025-07-16

    Transseptal Sheath Kit sterile barrier integrity issue with infection risk

    Boston Scientific is recalling VersaCross Transseptal Sheath Kits due to potential holes in the sterile barrier pouch that could compromise device sterility and lead to infection or sepsis.

    Product
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2025·2025-07-16

    Canturio Smart Extension implant components recalled for labeling error

    Canary Medical is recalling 106 Canturio® Smart Extension knee implant components due to incorrect labeling. Units were distributed in Indiana.

    Product
    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics fo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2090-2025·2025-07-16

    FDA Recalls Dental Resin Cartridges Due to Expiration Date Formatting Error

    STRATASYS recalled TrueDent Clear dental resin cartridges due to an expiration date formatting error that prevents the system from recognizing expired material. Affected units could allow use of expired resin in dental appliance fabrication.

    Product
    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2025·2025-07-16

    Stimulated EMG Kit with Hummingbird recalled for incorrect packaging and part number

    Neurovision Medical Products recalled the Hummingbird Stimulated EMG Kit (model I-D-BMF90) due to packaging that lists wrong part numbers and kit contents. Affected lot 050925219 was distributed to California.

    Product
    Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stim
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2092-2025·2025-07-16

    Dental resin cartridges recalled due to expiration date formatting error

    STRATASYS TrueDent Magenta dental resin cartridges are being recalled due to an expiration date formatting error that may allow expired resin to be used without system prevention, affecting 94 units nationwide.

    Product
    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2025·2025-07-16

    Dental 3D Printer Resin Expiration Date Formatting Error Recalled

    STRATASYS recalled 68 cartridges of TrueDent Yellow dental resin (Lot 22861) due to an expiration date formatting error where the day and month are switched. The error prevents system use and may allow expired material application.

    Product
    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2025·2025-07-16

    Dental resin cartridges recalled for expiration date formatting error

    Stratasys is recalling TrueDent Cyan dental resin cartridges due to a formatting error in the expiration date that switches the day with the month, and the system may not prevent use of expired material.

    Product
    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2035-2025·2025-07-09

    Philips BiPAP V30 Auto Ventilator Recalled for Incorrect Indication Labeling

    Philips Respironics recalled 5,958 BiPAP V30 Auto Ventilators worldwide due to incorrect labeling indicating use for respiratory failure patients. The device is not indicated for respiratory failure.

    Product
    BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2013-2025·2025-07-09

    Servo-u Ventilator System Recalled for Inaccurate Patient Circuit Compliance Measurement

    Maquet Critical Care's Servo-u Ventilator System is recalled due to potential inaccurate measurement of patient circuit compliance during testing. The issue results from incorrect pre-use leakage tests and use of an incompatible humidifier.

    Product
    Servo-u Ventilator System. Model Number: 6688600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2015-2025·2025-07-09

    Servo-u MR Ventilator System recalled for potential measurement inaccuracy

    Maquet Critical Care is recalling the Servo-u MR Ventilator System (Model 6888800) due to potential inaccuracy in patient circuit compliance measurement. The issue affects 129 units distributed nationwide in the US and Puerto Rico.

    Product
    Servo-u MR Ventilator System. Model Number: 6888800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2036-2025·2025-07-09

    BiPAP A30 Ventilators Recalled for Improper Respiratory Failure Indication

    Philips Respironics recalls BiPAP A30 and BiPAP Hybrid A30 ventilators due to labeling deficiency. The devices do not indicate for use in patients with respiratory failure.

    Product
    BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2014-2025·2025-07-09

    Servo-n Ventilator System recalled for patient circuit compliance measurement inaccuracy

    Maquet Critical Care AB is recalling the Servo-n Ventilator System (Model 6694800) due to potential inaccurate measurement of patient circuit compliance caused by incorrect pre-use leakage test procedures and use of incorrect active humidifier equipment.

    Product
    Servo-n Ventilator System. Model Number: 6694800.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2025·2025-07-09

    Medical device control material has incorrect platelet value assignments

    Siemens is recalling a diagnostic control product used with laboratory hematology systems. The control material has incorrect platelet value assignments.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2025·2025-07-09

    Medical Device Calibrator Recalled for Incorrect Platelet Value Assignments

    Siemens Healthcare has recalled 2,020 units of its ADVIA hematology calibrator due to incorrect platelet value assignments that could affect test accuracy. The calibrator is used in laboratories worldwide.

    Product
    ADVIA¿ 120/2120/2120i SETpoint Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    Diagnostic Chemistry Analyzer Software Error May Report Erroneous Test Results

    A software anomaly in the VITROS XT 7600 System allows test results to be reported using expired reagent packs when shelf expiration dates are omitted during manual entry, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2025·2025-07-09

    HemoCue Glucose Microcuvettes Recalled Due to Storage Degradation

    HemoCue Glucose 201 Microcuvettes are being recalled because transit conditions outside recommended storage limits may have compromised device stability. Affected products may deliver incorrect or delayed blood glucose test results.

    Product
    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2025·2025-07-09

    Medline IV Catheter Kits Recalled for Needle Retraction Failure

    Medline is recalling specific convenience kits containing BD Insyte Autoguard IV catheters because the needle may be slow to retract or fail to retract during insertion, posing a potential injury risk.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
    Category
    Medical Device
    Distribution
    Distributed nationwide