PlainRecalls

Cordis Corporation

Compiled from official public sources by the editorial team.

39 recalls on record · Latest: Nov 24, 2021

Cordis Corporation Recall Insight

Cordis Corporation appears on 39 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.038% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Nov 24, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 39 entries, severity tagging shows 7 critical, 31 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 39 of 39 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (39). The date window on this page runs from Oct 3, 2012 to Nov 24, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Nov 24, 2021

SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …

FDA Devices Moderate Nov 24, 2021

SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …

FDA Devices Moderate Nov 24, 2021

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary…

FDA Devices Moderate Nov 24, 2021

SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…

FDA Devices Moderate Nov 24, 2021

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…

FDA Devices Moderate Nov 24, 2021

SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …

FDA Devices Critical Sep 22, 2021

Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB

FDA Devices Critical Sep 22, 2021

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

FDA Devices Critical Sep 22, 2021

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B

FDA Devices Critical Sep 22, 2021

Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

FDA Devices Critical Sep 22, 2021

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A

FDA Devices Moderate Aug 18, 2021

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

FDA Devices Moderate Jul 21, 2021

Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of in…

FDA Devices Critical Mar 24, 2021

PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, …

FDA Devices Moderate Mar 18, 2020

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

FDA Devices Moderate Nov 6, 2019

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

FDA Devices Low Apr 24, 2019

Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of inte…

FDA Devices Moderate Nov 14, 2018

Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra poplit…

FDA Devices Moderate Jan 17, 2018

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

FDA Devices Moderate Apr 26, 2017

Cordis S.M.A.R.T. Flex Vascular Stent System

FDA Devices Moderate Jun 22, 2016

Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

FDA Devices Moderate Jun 22, 2016

Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)

FDA Devices Moderate Mar 23, 2016

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath …

FDA Devices Moderate Aug 26, 2015

RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal ar…

FDA Devices Moderate Jan 28, 2015

Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal art…

FDA Devices Moderate Sep 3, 2014

Cordis EMPIRA NC RX PTCA Dilatation Catheter

FDA Devices Moderate Sep 3, 2014

Cordis EMPIRA RX PTCA Dilatation Catheter

FDA Devices Moderate Jun 18, 2014

Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.

FDA Devices Moderate Nov 6, 2013

Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena…

FDA Devices Moderate Oct 9, 2013

Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or …

FDA Devices Critical Aug 14, 2013

Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP …

FDA Devices Moderate Jun 12, 2013

FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of ma…

FDA Devices Moderate Jun 12, 2013

FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for t…

FDA Devices Moderate Jun 12, 2013

FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for t…

FDA Devices Moderate Jun 12, 2013

FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for t…

FDA Devices Moderate Jun 12, 2013

FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of ma…

FDA Devices Moderate Feb 6, 2013

Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture …

FDA Devices Moderate Oct 3, 2012

Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09**…

FDA Devices Moderate Oct 3, 2012

Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.