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 ERAD LEFT, SHORT 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 SCR4.0, .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 SAL3.0, .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 JR3.0 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 FR3.5, .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 SAL2.0 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 ERAD RIGHT, .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 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, .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 RELAXED MOD 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 SCR5.0, .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 MAC4.0 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 ERAD RIGHT SHORT 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 ECR4.0, .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 ERAD LEFT 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 MAC5.0, .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 JL4.0, .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 LCB 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 JCL4.0, .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 CHAMP1.5 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 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 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, .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, .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, .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 CHAMP3.5, .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 SAR2.0 .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 AL2.0, .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 SL3.0, .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 EBU5.0 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 MAC3.75 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 CHAMP3.0, .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 JL3.5, .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 LCB 90CM, .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 JR4.5 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 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon… Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Cascade Abrazo aPTT Test Card Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sidus Stem-Free Shoulder Humeral Head 50-18 Incorrect labeling on the products package. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Kansas, New Jersey, New York, Ohio and Oklahoma named
- Medical device recall The Access Cortisol Reagent Cross contamination may have occurred between wells for the reagent pack. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Viva-ProE Systems Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. Class IIIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Accu-Chek Aviva II Meter - Product Usage: a Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu-Chek Performa II Meter - Product Usage: a Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquilex Fluid Control System component: Bag deflector The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proteus XR/a (SlOK : K993090) Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall B.Braun Infusomat Space Volumetric Infusion Pump Administration Set Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site). FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedOct 2, 2019ClassClass IStatusTerminatedWhereTexas
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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