Browse Device Recalls

40 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 40 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 40 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 1, 2021	SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is in...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Oct 1, 2021	SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind...	There is a potential for distal tip dislodgement or separation.	Class II	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,...	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 19, 2021	Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X	The balloon protective sheath may potentially be contaminated with a foreign material left over f...	Class II	Cordis Corporation
Jun 9, 2021	Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ...	The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.	Class II	Cordis Corporation
Feb 11, 2021	PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC053...	Distal tip may become separated from the lumen wire in specific lots.	Class I	Cordis Corporation
Jan 8, 2020	Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S	Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for ...	Class II	Cordis Corporation
Oct 4, 2019	Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.	Product was manufactured utilizing an expired inner body.	Class II	Cordis Corporation
Feb 7, 2019	Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui...	Frayed pieces of the mounting card being inside the primary packaging.	Class III	Cordis Corporation
Sep 5, 2018	Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to ...	Product may not meet the internal manufacturing shaft subassembly burst strength specification (F...	Class II	Cordis Corporation
Nov 15, 2017	Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated f...	Potential for cracked luer hubs	Class II	Cordis Corporation
Feb 16, 2017	Cordis S.M.A.R.T. Flex Vascular Stent System	Deployment Difficulty.	Class II	Cordis Corporation
May 4, 2016	Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)	Inability to deploy the stent or partial stent deployment.	Class II	Cordis Corporation
May 4, 2016	Cordis PRECISE (R) RX Nitinol Stent System (Biliary)	Inability to deploy the stent or partial stent deployment.	Class II	Cordis Corporation
Dec 31, 2015	CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a C...	Incorrect cannula of the sheath introducer (smaller than intended).	Class II	Cordis Corporation
Dec 22, 2014	Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses i...	One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was ...	Class II	Cordis Corporation
Jun 23, 2014	Cordis EMPIRA RX PTCA Dilatation Catheter	The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected...	Class II	Cordis Corporation
Jun 23, 2014	Cordis EMPIRA NC RX PTCA Dilatation Catheter	The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected...	Class II	Cordis Corporation
Apr 15, 2014	RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patient...	Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the h...	Class II	Cordis Corporation
Sep 27, 2013	Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of ...	Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orie...	Class II	Cordis Corporation
Aug 12, 2013	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd...	Due to a labeling error related to the conversion of the inner diameter of the catheter from inch...	Class II	Cordis Corporation
May 31, 2013	Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Acce...	Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE S...	Class II	Greatbatch Medical
Apr 23, 2013	FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL...	Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ...	Class II	Cordis Corporation
Apr 23, 2013	FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th...	Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ...	Class II	Cordis Corporation
Apr 23, 2013	FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th...	Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ...	Class II	Cordis Corporation
Apr 23, 2013	FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: Th...	Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ...	Class II	Cordis Corporation
Apr 23, 2013	FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FL...	Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to ...	Class II	Cordis Corporation
Mar 29, 2013	Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter*REF Cat. No.*466...	Correction to provide clarification and additional labeling to minimize likelihood on implanting ...	Class I	Cordis Corporation
Feb 5, 2013	Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovasc...	Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.	Class II	Cordis Corporation
Oct 29, 2012	Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi...	Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achiev...	Class II	Cordis Corporation
Jan 31, 2011	Sleek OTW*REF 426-1201XInflated Balloon Dia/mm1.25*Inflated Balloon...	On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilat...	Class II	Cordis Corporation
Jan 31, 2011	Sleek *OTW Ref 426-1501X*Inflated Balloon Dia/mm 1.5 Inflated Ballo...	On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dila...	Class II	Cordis Corporation

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.