Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
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
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
Nov 8, 2015 Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100... Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuou... Class II Vidco, Inc.
Nov 6, 2015 Destination Renal Guiding Sheath Intended for the introduction of interven... Based on internal investigation and testing that revealed the distal end of certain lots of Terum... Class II Terumo Medical Corporation
Nov 6, 2015 Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable ... Particulates: Complaints of rubber coring from the closure of injection vials. Class II Myco Medical Supplies Inc
Nov 2, 2015 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixat... It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the inco... Class II Synthes (USA) Products LLC
Oct 27, 2015 U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles wer... The firm had received a complaint alleging that a medical professional had difficulty inserting a... Class II Procedure Products, 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.