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 |
|---|---|---|---|---|
| Aug 18, 2020 | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AM... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description):... | XXX | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP3... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item N... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProS... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-10... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Feb 15, 2019 | QuickTox 5 Panel Drug Screen DipCard | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere... | Class III | Ameditech Inc |
| Dec 15, 2017 | Alere iScreen Dx Urine Drug Screen Card | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti... | Class III | Ameditech Inc |
| Sep 30, 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... | Product was released to market without the adulteration strip included in the product. | Class III | Ameditech Inc |
| Jun 26, 2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl... | The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl... | Class III | Ameditech Inc |
| Nov 16, 2015 | ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-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 | EDI BZO Uncut Sheet - Cup*, Item No. 160170 | 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 | 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-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 | ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3 | 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 6 Drugs w/Adul, Item No. PSCupA-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 | DrugSmart 9 Test Cup (BUP), Item No. 60960D | 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 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 | 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 | RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA | 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 Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-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 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 w/Adult (AU), Item No. PSDA-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 Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D | 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 10 Test Cup (PCP & OXY), Item No. 61020D | 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 CLIA Waived w/Adulteration, Item No. IMCA-7MT-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 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 | 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 8 Panel Dip Card, Item No. PSD-8P | 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 6 DRUG CASSETTE, Item No. MTPA-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 | ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 | 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 w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA... | 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 11 Pnl Drug Screen Cup w/ Adult, 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 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3 | 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 | DrugCheck Waived 12 Panel Cup w/Adult, Item No. 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 | 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300,... | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | 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.