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Medical Components, Inc. (dba MedComp)

United StatesFDA applicant, unverified

Devices
9
FDA recalls
461 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls46

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 3
  • 2018 22
  • 2019 4
  • 2020 1
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

15 initiated before 2017

Showing the 10 most recent of 46 recalls.

  • 2021

    • 13 Jan 2021 Z-1184-2021 Class II Ongoing The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure. Distribution: US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021 Submission number: K132177

  • 2020

    • 27 Jul 2020 Z-2940-2020 Class II Terminated Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer Distribution: AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA Submission number: K994105

  • 2019

    • 13 Mar 2019 Z-1149-2019 Class II Terminated Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. Distribution: Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV. Submission number: K893439
    • 13 Mar 2019 Z-2215-2019 Class II Terminated Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. Distribution: US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV. Submission number: K893439
    • 13 Mar 2019 Z-2216-2019 Class II Terminated Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. Distribution: US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV. Submission number: K893439
    • 13 Mar 2019 Z-2217-2019 Class II Terminated Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. Distribution: US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV. Submission number: K893439

  • 2018

    • 1 Oct 2018 Z-0222-2020 Class II Terminated When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement. Distribution: Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada,…
      Full distribution text Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.
      Submission number: K170934
    • 12 Jul 2018 Z-2932-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2933-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2934-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
Show the 25 most recent of 46 recalls

  • 2018

    • 12 Jul 2018 Z-2935-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2936-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2937-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2938-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2939-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2940-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2941-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 12 Jul 2018 Z-2942-2018 Class II Terminated The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death. Distribution: Nationwide distribution; worldwide distribution. Submission numbers: K842416, K983511
    • 23 Feb 2018 Z-1118-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570
    • 23 Feb 2018 Z-1119-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570
    • 23 Feb 2018 Z-1120-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570
    • 23 Feb 2018 Z-1121-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K981125
    • 23 Feb 2018 Z-1122-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570
    • 23 Feb 2018 Z-1123-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570
    • 23 Feb 2018 Z-1124-2018 Class II Terminated There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
      Submission number: K022570

Frequently asked questions

How many devices does Medical Components, Inc. (dba MedComp) have in the registry?

The registry currently lists 9 devices for Medical Components, Inc. (dba MedComp). Devices recorded under merged duplicate company entries are counted once.

Which registries list Medical Components, Inc. (dba MedComp)'s devices?

Among its 9 most recently registered devices, Medical Components, Inc. (dba MedComp) has devices listed in FDA 510(k) (9 devices).

What risk classes do Medical Components, Inc. (dba MedComp)'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Medical Components, Inc. (dba MedComp)'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Medical Components, Inc. (dba MedComp)?

FDA recall records list 46 recalls initiated by Medical Components, Inc. (dba MedComp), the most recent initiated on 2021-01-13. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Medical Components, Inc. (dba MedComp) in the registry?

The most recently registered devices listed for Medical Components, Inc. (dba MedComp) include Trio-CT Triple Lumen Catheter, C3 Wave System, Trio-CT­® Triple Lumen Catheter w/ Curved Extensions and 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes.

Generated automatically from registry data and not verified by a human reviewer.