Medical Components, Inc dba MedComp
Complete recall history across all FDA and CPSC categories — 38 total recalls
Medical Components, Inc dba MedComp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (38)
FDA medical device enforcement actions by Medical Components, Inc dba MedComp
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 13, 2021 | Power Injectable CT Port insertion kits - Product Usage: is an implantable ac... | The 5F Dignity CT Port kits were packaged with the incorrect size port. The k... | Class II |
| Jul 27, 2020 | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Kits were packaged with the incorrect size valve peelable introducer. The kit... | Class II |
| Mar 13, 2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable intro... | Class II |
| Mar 13, 2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable intro... | Class II |
| Mar 13, 2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable intro... | Class II |
| Mar 13, 2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.... | Tray label indicates the kits are packaged with a 15F "valved" peelable intro... | Class II |
| Oct 1, 2018 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 applicat... | Class II |
| Jul 12, 2018 | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ ... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T11... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodi... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC0210... | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | The suture wings have the potential to crack or break. Potential patient inju... | Class II |
| Feb 23, 2018 | 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product ... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair ... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The M... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medc... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Me... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repai... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 ... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 ... | There is the potential for connection failures related to the female two-part... | Class II |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266... | There is the potential for connection failures related to the female two-part... | Class II |
| Nov 22, 2017 | 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyuretha... | The kit was packaged with the incorrect guidewire. The label indicates the ki... | Class II |
| May 25, 2017 | 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyuretha... | The kit was packaged with the incorrect introducer needle size. The label in... | Class II |
| Feb 23, 2017 | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... | The 9.6F port kits were packaged with the incorrect valved peelable introduce... | Class II |
| May 5, 2016 | Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individua... | This recall has been initiated due to the product labeled with the incorrect ... | Class II |
| Feb 5, 2015 | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lum... | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Cathet... | Class II |
| Jan 28, 2015 | 9F Plastic Dual Port; The port systems are totally implantable vascular acces... | The dual port with catheters was not covered under FDA clearance. | Class II |
| Jan 21, 2015 | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 2... | Drug products contained within the kits may have been rendered ineffective by... | Class II |
| Aug 4, 2014 | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is i... | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath II... | Class II |
| Dec 13, 2012 | REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product ... | The affected product was packaged with the incorrect introducer needle. The ... | Class II |
| Apr 2, 2012 | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable... | Product was packaged with the incorrect port and does not match the label. T... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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