Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2015 | Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthet... | There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Wor... | Class I | Draeger Medical, Inc. |
| 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 |
| Nov 2, 2015 | OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product ... | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan... | Class I | Insulet Corporation |
| Nov 2, 2015 | OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Produc... | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan... | Class I | Insulet Corporation |
| 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 | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... | Class I | Boston Scientific Corporation |
| Oct 9, 2015 | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... | Class I | Boston Scientific Corporation |
| Oct 7, 2015 | Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angi... | Reports of catheter tip splits and or separation. Loss of device function, medical intervention t... | Class I | Cook 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 |
| Sep 29, 2015 | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric... | Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ ... | Class I | Alcon Research, Ltd. |
| Aug 6, 2015 | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 5950... | SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mec... | Class I | SynCardia Systems Inc. |
| Aug 4, 2015 | PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degr... | Unexpected rate of postoperative fractures resulting in the need for revision surgery. | Class I | MicroPort Orthopedics, Inc. |
| Jul 21, 2015 | Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect... | Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring... | Class I | CareFusion 303, Inc. |
| Jul 16, 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jul 15, 2015 | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... | Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. | Class I | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Jul 13, 2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Ca... | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... | Class I | Insulet Corporation |
| Jul 13, 2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Cat... | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... | Class I | Insulet Corporation |
| Jul 13, 2015 | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... | Class I | Draeger Medical, Inc. |
| Jul 2, 2015 | Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. ... | Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... | Class I | Cook Inc. |
| Jul 2, 2015 | Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiog... | Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... | Class I | Cook Inc. |
| Jul 2, 2015 | Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use i... | Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... | Class I | Cook Inc. |
| Jun 3, 2015 | Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and... | Administration of inappropriate quantities of fluid can result, with the potential to cause injur... | Class I | Elite Biomedical Solutions LLC |
| Jun 3, 2015 | Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and... | Administration of inappropriate quantities of fluid can result, with the potential to cause injur... | Class I | Elite Biomedical Solutions LLC |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 2... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| May 18, 2015 | M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (meta... | Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinecti... | Class I | Zimmer, Inc. |
| May 14, 2015 | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Huds... | The intake port may be blocked which can cause the bag to fail to fill. | Class I | Teleflex Medical |
| May 13, 2015 | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An inte... | Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have ... | Class I | Ethicon Endo-Surgery Inc |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 2, 2015 | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... | Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch du... | Class I | Synovis Surgical Innovations, Inc. |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 110... | Complaints with the HVAD Retraction of Pins within the driveline connector. | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / ... | HeartWare has received complaints relating to damage or bent connection pins within the power sup... | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... | Complaints with the HVAD Internal Controller Alarm Battery failures. | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... | Failures of the splice repair kit if exposed to excessive force. | Class I | HeartWare Inc |
| Apr 15, 2015 | ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS... | There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) ... | Class I | Alcon Research, Ltd. |
| 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 2, 2015 | FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ... | In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas l... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Mar 30, 2015 | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO... | Potential for clear extension tube to separate from the hub, which could result in blood loss and... | Class I | OriGen Biomedical, Inc. |
| Mar 30, 2015 | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO... | Potential for clear extension tube to separate from the hub, which could result in blood loss and... | Class I | OriGen Biomedical, 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 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 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 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 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 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 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 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. |
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.