Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Varicella Zoster Virus 7.0 ml Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall CD117, c-kit (YR145) 1.0 ml Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific… Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of… Storage temperature listed on the label was incorrect. Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJun 7, 2017ClassClass IIIStatusTerminatedWhereIllinois
- Medical device recall Nutrient Gelatin, Acumedia Incorrect expiration date was listed on the label. Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Maine named
- Medical device recall Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use… Incorrect expiration date on label. Class IIIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and… nail not properly engaging with the targeting jig due to certain undersized specification Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx… Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Idaho, Illinois, Maryland, Minnesota, New York, Ohio and Pennsylvania
- Medical device recall Cardinal, Digital Bariatric Scale 1) One complaint of a seat on a scale failing unexpectedly which can cause an injury. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Assist Bed Rail - 6632 A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly. Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Exact Sciences Sample Mixer 2 Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder… Class IIFDA’s classJun 7, 2017in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedJun 7, 2017ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall HeartMate¿ II LVAS with Pocket Controller St. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall HeartMate¿ II LVAS with Pocket Controller St. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall HeartMate¿ II LVAS with Pocket Controller St. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia’ “’, Claria’”’, and Compia’”’ Quad CRT-D MRI… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall 10-1398M - SpF-PLUS Implantable Stimulator Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall StatLock¿ IV Premium Catheter Stabilization Device StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range. Class IIIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump Cardiovascular Systems, Inc. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Merge Cardio software Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereArizona, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, North Carolina, New York, Ohio, Oklahoma, Texas and Vermont
- Medical device recall Microalbumin Reagent Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein… Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ceftriaxone TX 32 US S30 Potential performance issue on strain categorization. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New York, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas and Washington named
- Medical device recall PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PE CONNECTOR 5 Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory Recalled by FDA on May 31, 2017 Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Flat Drain Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 19FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt PVC Round Drain, 10FR W/Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Round Drain, 7FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Round Drain, 10FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Round Drain, 15FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Round Drain, 19FR Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Class IIFDA’s classMay 31, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2017ClassClass IIStatusTerminatedWhereNationwide
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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