Browse Device Recalls
38 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 38 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 kits include a 6.6F p... | Class II | Medical Components, Inc dba MedComp |
| 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 kits include a 15F inst... | Class II | Medical Components, Inc dba MedComp |
| 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 introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| 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 introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| 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 introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| 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 introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Oct 1, 2018 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Up... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| 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 kit contains a marked ... | Class II | Medical Components, Inc dba MedComp |
| 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 indicates the kit cont... | Class II | Medical Components, Inc dba MedComp |
| 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 introducer. The label states ... | Class II | Medical Components, Inc dba MedComp |
| 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 expiration date. | Class II | Medical Components, Inc dba MedComp |
| 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 Catheter, SLX Catheter, Tr... | Class II | Medical Components, Inc dba MedComp |
| 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 | Medical Components, Inc dba MedComp |
| 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 a duplicate sterili... | Class II | Medical Components, Inc dba MedComp |
| 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 III instead of 28CM. | Class II | Medical Components, Inc dba MedComp |
| 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 kit label indicates ... | Class II | Medical Components, Inc dba MedComp |
| 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. The kit is labeled as... | Class II | Medical Components, Inc dba MedComp |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.