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 Regard, Item Number: 800528005 Sterile, GS0612E - 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: 800533002 Sterile, GS0606B - Abdominal 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: 800533003 Sterile, GS0606C - Abdominal 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: 800535002 Sterile, LD0620B - C Section - New Braunfels 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: 800535002 Sterile, LD0620B - C Section - New Braunfels 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: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa 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: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa 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: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa 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: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa 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: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa 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: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa 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: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa 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: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa 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: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa 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: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa 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: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa 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: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa 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: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa 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: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa 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: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa 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: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa 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: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa 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: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa 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: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa 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: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa 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: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa 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: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa 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: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa 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: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa 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: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa 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: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa 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: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo 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: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo 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: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa 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: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa 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: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa 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: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland 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: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland 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: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa 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: 800401001, Sterile, GS0470A - Lap 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: 800401002, Sterile, GS0470B - Lap 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: 800407004, Sterile, OR0476D - 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: 800408002, Sterile, LD0477B - C-Section 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: 800408003, Sterile, LD0477C - C-Section 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: 800408004, Sterile, LD0477D - C-Section 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: 800409002, Sterile, GS0478B - Lap Chole 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: 800409003, Sterile, GS0478B - Lap Chole 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: 800410004, Sterile, CV0479D- 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
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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