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 11 Panel Card (OPI 300) w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 12-Panel Dip Drug Screen with adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 6 Panel Cup Body and Lid w/Adult (AU) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall BZO Strip Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall CLIA RDTC 12-Panel Cup (w/Adulteration) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugCheck Waived 12 Panel Cup w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 10 Test Cup (PCP & OXY) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 11 Test Cup Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 12 Test Cup (Multi & BUP) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart 9 Test Cup (BUP) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart Cup 10 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DrugSmart Dip AMP/OPI2/COC/THC/BZO Test Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall EDI BZO Uncut Sheet - Cup* Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall iCup DX 10 Panel w/Adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall iCup DX 11 Panel w/ Adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall iCup DX 12 Panel w/ Adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall iCup DX 6 Panel w/Adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall iCup DX 8 Panel w/Adulterant Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immutest 10 Pnl Drug Screen Cup w/ Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immutest 11 Pnl Drug Screen Cup w/ Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immutest 5 Pnl Drug Cup w/ Adult -waived Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immutest 12 Panel Cup w/Adulteration Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ImmuTest 12 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ImmuTest Cup 7-panel w/ Adulteration Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immutest Cup CLIA Waived w/Adulteration Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Micro Screen 6 Panel Cup with Adult (AU) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 10 Drug Panel Cassette Test Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 10 Panel Cup Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScProScreen 10 Panel Cup with Adulterants Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 10 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 10 Panel Dip Card w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 12 Drug Cup w/Adulteration Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 12 Panel Cup w/Adult. Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 12 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 5 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 5 Panel Dip Card w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 6 Panel Cassette w/Adult (AU) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 6 Panel Cup w/Adult (AU) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 6 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 6 Panel Dip Card w/Adult (AU) Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 6 Panel Dip Drug Screen Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 7 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 8 Panel Dip Card Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 8 Panel Dip Card w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 8 Panel Dip Card w/Adult Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ProScreen 9 Panel Cup w/Adulterants Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which… Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
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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