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 |
|---|---|---|---|---|
| Apr 20, 2015 | 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock... | ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... | Class II | ICU Medical, Inc. |
| Apr 17, 2015 | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping... | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 ... | Class II | Biosense Webster, Inc. |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail... | Class II | Nihon Kohden America Inc |
| Apr 13, 2015 | COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an is... | Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on Uni... | Class II | Beckman Coulter Inc. |
| Apr 10, 2015 | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine S... | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been bot... | Class II | Alphatec Spine, Inc. |
| Apr 9, 2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... | Some rods may not meet the appropriate traceability requirements including the lot number. Some ... | Class III | Spinal Elements, Inc |
| Apr 6, 2015 | Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfa... | GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental becaus... | Class II | GA Industries |
| Apr 3, 2015 | CareFusion AVEA ventilator, all models. Product Usage: A continuous venti... | A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occl... | Class I | Carefusion 211 Inc dba Carefusion |
| Apr 1, 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... | Class II | Dako North America Inc. |
| Mar 30, 2015 | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4... | A limited number of VPS G4 Consoles are being recalled due to noncompliance with International El... | Class II | VasoNova, Inc. |
| Mar 25, 2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw Sys... | Increase of field reports involving issues with the TIGERPAW System II resulting in possible tiss... | Class I | Laax, Inc. |
| Mar 25, 2015 | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator S... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw Sys... | Increase of field reports involving issues with the TIGERPAW System II resulting in possible tiss... | Class I | Laax, Inc. |
| Mar 24, 2015 | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000... | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | Class II | Nidek Inc |
| Mar 23, 2015 | CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent | One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may... | Class II | BD Biosciences, Systems & Reagents |
| Mar 19, 2015 | SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and ... | Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has recei... | Class II | Biosense Webster, Inc. |
| Mar 18, 2015 | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter ... | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Mo... | Class II | Hansen Medical Inc |
| Mar 17, 2015 | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage... | A drop in staining intensity over time has been observed. These lots may not meet their labeled s... | Class II | Biocare Medical, LLC |
| Mar 16, 2015 | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek M... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pac... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Me... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical E... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Mic... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medic... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Mi... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Med... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2015 | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies t... | Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batc... | Class II | Focus Diagnostics Inc |
| Mar 13, 2015 | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Accessories assembled, self-contained package, Catalog No. I-104 vir... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Mater... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. T... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 12, 2015 | Alaris PC units, Model No. 8015. Infusion pump. | CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur up... | Class II | CareFusion 303, Inc. |
| Mar 11, 2015 | ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and ... | Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties. | Class I | Hummingbird Med |
| Mar 11, 2015 | INFX-8000V Interventional Angiography System. CAT-880B catheterization table... | The table base rotational brake that holds the table top may not always be engaged when any force... | Class II | Toshiba American Medical Systems Inc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 5.0x8mm, Article No. 36710. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x13mm, Article No. 36708. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
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.