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.

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DateProductReasonClassFirm
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.