Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 20, 2015 | ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Ab... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs ... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300)... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs ... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP),... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. ... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 20, 2015 | 10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests ar... | Ameditech is recalling drug abuse tests because they have shown reduced reactivity. | Class II | Ameditech Inc |
| Oct 13, 2015 | NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plasti... | The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause th... | Class II | Ceterix Orthopedics, Inc. |
| Oct 13, 2015 | Access CEA Assay, Part No. 33200. For the quantitative determination of Carc... | Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. | Class II | Beckman Coulter Inc. |
| Oct 13, 2015 | Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7... | A component on the systems power board can fail in a manner which can cause the ventilator to shu... | Class I | Event Medical LTD |
| Oct 9, 2015 | SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic... | CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. | Class II | CareFusion 303, Inc. |
| Oct 9, 2015 | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Han... | Update to labeling for the miraDry Console to remind users to only use approved lubricants in a t... | Class II | Miramar Labs, Inc. |
| Oct 7, 2015 | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro... | Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 2, 2015 | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF145... | Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential... | Class II | Focus Diagnostics Inc |
| Oct 1, 2015 | ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used... | Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the c... | Class I | Hummingbird Med |
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.