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 Merge PACS software Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the… Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear… Siemens became aware of a defective weld seam at overhead suspensions. Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CELL-DYN Ruby System: List Number: 08H6701 The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage Class IIFDA’s classMar 15, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 15, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic SynchroMed II Implantable Drug Infusion System Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended… Olympus has received complaints regarding the breakage of the endoscope’s insertion tube bending section during surgical procedures. Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EliA Sample Diluent, Article number, 83-1023-01 Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Wisconsin and West Virginia
- Medical device recall Siemens ADVIA Centaur Systems Calibrator A Kits Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur,… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Siemens ADVIA Centaur Systems Calibrator A Kits Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur,… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Siemens ADVIA Centaur Systems Calibrator A Kits Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur,… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Abdominoplasty Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Angio Pack, part number AMS6711 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Anterior Cervical Fusion Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Arthroscopy Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Arthroscopy Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Augmentation Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Extended Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Face Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Kit, part number CMP1109(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Pack (1185), part number AMS6560 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Setup Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Setup Tray The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basic Tray, part number PSS1559(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Basin Pack, part number AMS2497 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Bayview Abdominoplasty Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Bayview Breast Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Bleph Pack, part number AMS3325(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Breast Augmentation Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Breast Recon Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Brow Pack, part number PSS1785(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Catheter Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Chest Breast Drape The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall C-Tray Pack, part number PSS2707(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Custom Breast Augmentation Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Custom Pack - with Introducer Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Custom Venous Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall D & C Kit, part number CMP1466(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall D & C Pack, part number AMS4796(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall D&C/Cysto Pack The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
- Medical device recall Dr Bragg Vein Tray - RX The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report26 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia and Washington
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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