Stradis Medical, LLC dba Stradis Healthcare recalls

5 official recalls and safety alerts involving Stradis Medical, LLC dba Stradis Healthcare since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Stradis Medical, LLC dba Stradis Healthcare or the relevant agency.

  1. 2022-12-21
  2. US
    Drugs & medicalClass II

    Stradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,

    Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

    FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS nationwide distribution, and Canada.Official notice →
  3. 2022-08-24
  4. US
    Drugs & medicalClass II

    Stradis Medical, LLC dba Stradis Healthcare recalls NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700

    The sterile barrier may be compromised.

    FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS Nationwide distribution in the state of SC.Official notice →
  5. 2022-04-13
  6. US
    Drugs & medicalClass II

    Stradis Medical, LLC dba Stradis Healthcare recalls Coryell Memorial Hosp Total, Joint Pack - Surgical Kit

    The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

    FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS Nationwide distribution in the states of IN, TX, and PA.Official notice →
  7. 2021-12-29
  8. US
    Drugs & medicalClass II

    Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

    This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

    FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice →
  9. 2021-10-27
  10. US
    Drugs & medicalClass II

    Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit

    Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

    FDA · DeviceStradis Medical, LLC dba Stradis HealthcareDistributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK,…Official notice →