Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Morphine Strips Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Morphine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall PCP Test (Strip) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall PCP Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall THC Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall THC Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Ketamine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Ketamine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Buprenorphine Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Buprenorphine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Oxycodone Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Oxycodone Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Alcohol Test, Urine Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Propoxyphene Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Propoxyphene Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methylphenidate Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methylphenidate Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Fentanyl Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Fentanyl Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Fentanyl Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Clonazepam Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall K2 (synthetic Marijuana) Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall K2 (synthetic Marijuana) Test card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Troponin I test Card (serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Troponin I test Card (Whole Blood) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Cardiac Panel Test (Serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Cardiac Panel Test Card (Whole Blood) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Myoglobin Test Card (Serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Myoglobin Test Card (Whole Blood) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall CK-MB Test Card (serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall CK-MB Test Card (Whole Blood) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall Saber 100ml Infection Control PVC Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
- Medical device recall 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection… Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wyoming
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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