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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.