Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 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 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 4, 2015 | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. ... | The OAD saline sheath outer layer may flake off from the catheter due to friction between the out... | Class I | Cardiovascular Systems, Inc. |
| Feb 23, 2015 | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath... | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end ... | Class I | Medtronic Inc. Cardiac Rhythm Disease Management |
| Feb 3, 2015 | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... | Reports of formation of char adherent to the proximal part of the distal tip electrodes | Class I | Boston Scientific Corp |
| Jan 31, 2015 | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure ... | The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed ... | Class I | Western / Scott Fetzer Company |
| Jan 16, 2015 | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: ... | The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commerc... | Class I | HeartWare Inc |
| Jan 12, 2015 | MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01... | Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm I... | Class I | Teleflex Medical |
| Jan 9, 2015 | Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. | The MRI system safety feature, which lowers the magnetic field in emergency situations, may not w... | Class I | Alltech Medical Systems America Inc |
| Jan 7, 2015 | This correction applies to all GE Healthcare MRI systems with superconducting... | At certain sites, the MRU may not be connected to the magnet. In emergency situations, a discon... | Class I | GE Healthcare |
| Dec 10, 2014 | Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, ... | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... | Class I | Covidien |
| Dec 10, 2014 | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... | Class I | Covidien |
| Dec 5, 2014 | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 4, 2014 | MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-81... | Connector mount cracks which may lead to a leak failure during use and necessitate immediate repl... | Class I | Teleflex, Inc. |
| Dec 3, 2014 | GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electro... | The firm discovered that during the use of these defibrillation electrodes a possibility for arci... | Class I | Leonhard Lang Gmbh |
| Nov 29, 2014 | Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidif... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 | LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... | Class I | Magellan Diagnostics, Inc. |
| Nov 29, 2014 | Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 | LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... | Class I | Magellan Diagnostics, Inc. |
| Nov 29, 2014 | Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing ... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with Ai... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification ... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 19, 2014 | Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 11, 2014 | ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For us... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
| Nov 11, 2014 | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
| Nov 11, 2014 | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, 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.