Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070 There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.5, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
- Medical device recall SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070” There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IStatusTerminatedWhereNo state named
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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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