The Recall Desk

Manufacturer

Medical Components, Inc dba MedComp

38 recalls in our database name Medical Components, Inc dba MedComp as the manufacturing or recalling firm.

What the numbers show

Total
38
Critical
0
Severe
9
Most recent
2021-03-17

Of the 38 recalls from Medical Components, Inc dba MedComp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (24%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 38

  • ModerateFDA (Devices)·Z-1184-2021·2021-03-17

    MedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size

    Medical Components, Inc. is recalling 96 Power Injectable CT Port kits because they contain 6.6F ports instead of the correct 5F size, which may prolong surgical procedures.

    Product
    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2940-2020·2020-09-16

    Medcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size

    Medical Components, Inc. is recalling 132 Medcomp Titan HD catheter kits because they were packaged with a 15F valve instead of the correct 16F valve.

    Product
    Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0222-2020·2019-11-06

    MedComp C3 Wave App Recalled Due to ECG Display Failure

    Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.

    Product
    C3 Wave App, v. 2.0.5
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2215-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.

    Product
    14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2217-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.

    Product
    14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2216-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.

    Product
    14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2019·2019-04-24

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved when it is non-valved.

    Product
    14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2941-2018·2018-09-05

    MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2939-2018·2018-09-05

    MedComp Recalls Soft-Line Duo-Flow Double Lumen Catheter Trays

    Medical Components, Inc dba MedComp is recalling Soft-Line Duo-Flow Double Lumen Catheter Trays because suture wings may crack or break, posing a risk of patient injury.

    Product
    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2933-2018·2018-09-05

    MedComp Recalls Double Lumen CRRT Catheter Sets Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling specific hemodialysis catheter insertion kits because the suture wings may crack or break, posing a risk of patient injury.

    Product
    Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2932-2018·2018-09-05

    MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking Risk

    Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2936-2018·2018-09-05

    MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking

    Medical Components, Inc. is recalling hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2938-2018·2018-09-05

    MedComp Duo-Flow Double Lumen Catheters Recalled for Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow Double Lumen Catheters because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2940-2018·2018-09-05

    MedComp Recalls Soft-Line Duo-Flow Catheters Due to Suture Wing Cracking

    Medical Components, Inc. is recalling Soft-Line Duo-Flow catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, or air emboli.

    Product
    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2935-2018·2018-09-05

    MedComp Recalls Duo-Flow IJ Full Trays Due to Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2934-2018·2018-09-05

    MedComp Recalls Duo-Flow Hemodialysis Catheter Sets Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack or break, posing a risk of patient injury.

    Product
    Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2937-2018·2018-09-05

    MedComp Duo-Flow XTP Straight Full Set Recalled for Suture Wing Cracking

    Medical Components, Inc. is recalling Duo-Flow XTP Straight Full Sets because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.

    Product
    Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2942-2018·2018-09-05

    MedComp Recalls Duo Flow Double Lumen Catheters Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2018·2018-04-04

    MedComp Recalls CT Port Kits Packaged with Incorrect Unmarked Guidewire

    Medical Components, Inc. is recalling 8F Plastic Dignity Low Profile CT Port kits because they were packaged with unmarked guidewires instead of the marked ones indicated on the label.

    Product
    8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1124-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2018·2018-03-28

    MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

    Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.

    Product
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1118-2018·2018-03-28

    MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk

    Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk

    Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.

    Product
    REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2018·2018-03-28

    MedComp Two Part Adapter Recall for Potential Connection Failures

    Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide