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 VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N328), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P643), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N330), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N335), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N339), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P645), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N345), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Fungal Susceptibility card (AST-YS08), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P649), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N350), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Positive Susceptibility card (AST-P650), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N354), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-N364), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall M3150 Information Center Local Database Potential for early component failure. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F Lack of sterility assurance. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F Lack of sterility assurance. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F Lack of sterility assurance. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F Lack of sterility assurance. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual… Due to possibility of insufficient sterilization. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Pereyra-Raz Ligature Carrier reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pereyra Ligature Carrier 75 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stamey Needle reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Clarke-Reich Laparoscopic Knot Pusher reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 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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