Medical devices, 2017
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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 Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
- Medical device recall Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereLouisiana and Texas
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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