Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue(R) Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port,… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Clear Fenestrated Drape with Adhesive Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Spring-Wire Guide Introducer Catheter Assembly Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TheraCath(R) Epidural Catheter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 0.2 Micron Flat Epidural Filter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arrow-Johans” ECG Adapter for Right Atrial Electrocadiography (RAECG) Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROW JACC with Chlorag+ard Technology Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 10 cc Luer-Slip Loss of Resistance Syringe Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for… Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arterial Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PICC Catheter Trimmer Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Peel Away Sheath over Dilator Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Echogenic Needle Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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