Medical devices, 2019
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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 Hudson RCI Sheridan: 1) CF 6.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Hudson RCI Sheridan: 1) Preformed 6.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Hudson RCI Sheridan: 1) Uncuffed 6.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Hudson RCI Sheridan: 1) HVT 6.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Sheridan/CF Novaplus 7.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Sheridan/HVT: 1) Novaplus 7.0 mm This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Liquid Cardiac Control Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Puerto Rico and West Virginia
- Medical device recall Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version… Insulin dosing calculations were erroneously high. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow PICC powered by Arrow VPS Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC Kit Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC Kit Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC Kit Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS” Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS” Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance” PICC pre loaded with Arrow¿ VPS” Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS” Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS” Precision Stylet Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance PICC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ JACC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance JACC Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrowg+ard Blue Advance Midline Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC with Chlorag+ard¿ Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC with Chlorag+ard Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC with Chlorag+ard¿ Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow¿ PICC with Chlorag+ard¿ Technology Lidstock states the incorrect expiration date for the product Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) The bearings of the saw attachments were ungreased. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Kansas, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee and Texas
- Medical device recall 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) The bearings of the saw attachments were ungreased. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Kansas, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee and Texas
- Medical device recall EGIA 30 ARTICULATING MED THICK SULU The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusOngoingWhereNationwide
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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