Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX.… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft,… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi and Texas
- Medical device recall regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle… The kits contain an equipment glove component which may contain splits or holes compromising the sterility. Class IIFDA’s classOct 14, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 14, 2015ClassClass IIStatusTerminatedWhereLouisiana, Mississippi 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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