Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
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 13, 2015 Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2... Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement o... Class II Edwards Lifesciences, LLC
Nov 12, 2015 Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end... CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during... Class II CareFusion 303, Inc.
Nov 10, 2015 Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a m... The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image... Class II Shimadzu Medical Systems
Nov 6, 2015 MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; T... Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ... Class II Cardica, Inc.
Nov 6, 2015 MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30... Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ... Class II Cardica, Inc.
Nov 5, 2015 Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administe... CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection a... Class II CareFusion 303, Inc.
Nov 4, 2015 Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N... Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation... Class II Ormco/Sybronendo
Nov 3, 2015 Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, ... Leads may have been compromised during the manufacturing process, with cuts in the insulation lay... Class I St Jude Medical Cardiac Rhythm Management Division
Oct 30, 2015 BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5... Three lots of CD64 (MD22) are contaminated with CD4 antibody. Class II Becton, Dickinson and Company, BD Biosciences
Oct 28, 2015 rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; ... These sensors were manufactured with incompatible configurations. This could result in sensors th... Class II Masimo Corporation
Oct 28, 2015 DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. ... Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender ... Class II Implant Direct Sybron Manufacturing, LLC
Oct 27, 2015 Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS... It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - ... Class III Lab Vision Corporation
Oct 23, 2015 Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A... Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter hav... Class II Medtronic Vascular, 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

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.