Browse Device Recalls
109 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 109 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 109 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 16, 2015 | iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (... | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 5 Panel Dip Card, Item No. PSD-12BUP | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6B... | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Panel Cup, Item No. PSCup-10M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart 11 Test Cup, Item No. 61127D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of ... | Class III | Ameditech Inc |
| Nov 16, 2015 | BZO Strip Dip Card (300ng/ml)*, Item No. 100170 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 10-Panel Pipette Drug Screen, Item No. PSP-10M | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Nov 16, 2015 | DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech Inc |
| Oct 20, 2015 | iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Pane... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of A... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abus... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. T... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Pan... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pn... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI30... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Ab... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs ... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.