Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2015 | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sci... | Potential for micropores to form, allowing fluid to enter the hollow handle. | Class II | Synthes (USA) Products LLC |
| Jul 29, 2015 | NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product ... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); Kim... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | Software version 4.44A utilized on the BD MAX System | The BD MAX System software version 4.44A contains a software anomaly that has the potential to af... | Class II | BD LIFE SCIENCES |
| Jul 29, 2015 | KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Prod... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, D... | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... | Class II | Halyard Health, Inc |
| Jul 29, 2015 | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) an... | Labeling changes were made related to MR conditions that align with standard definitions for MR S... | Class II | Synthes (USA) Products LLC |
| Jul 28, 2015 | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, ... | When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one p... | Class II | Siemens Healthcare Diagnostics Inc |
| Jul 28, 2015 | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. | The device was assembled without screw hole plugs. | Class II | Biomet, Inc. |
| Jul 28, 2015 | Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For t... | Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit gr... | Class II | Beckman Coulter Inc. |
| Jul 28, 2015 | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part nu... | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a d... | Class II | OrthoPediatrics Corp |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to m... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ... | The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty du... | Class II | Leica Microsystems, Inc. |
| Jul 27, 2015 | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... | Class III | Cepheid |
| Jul 27, 2015 | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... | Class III | Cepheid |
| Jul 27, 2015 | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #14... | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... | Class II | Trumpf Medical Systems, Inc. |
| Jul 27, 2015 | Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detec... | The DPM 7 Monitors may display a black screen. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 27, 2015 | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution becaus... | Class II | Advanced Sterilization Products |
| Jul 27, 2015 | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to meas... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 ... | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... | Class II | Sunrise Medical (US) LLC |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to mea... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #15... | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... | Class II | Trumpf Medical Systems, Inc. |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Use... | Low red blood cell control recoveries and low results for red blood cell patient samples when usi... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to m... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #15589... | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... | Class II | Trumpf Medical Systems, Inc. |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to ... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to mea... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Man... | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... | Class II | Trumpf Medical Systems, Inc. |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to me... | Software defect; programming errors in the blood flow probes EPROM. Transonic received several c... | Class II | Transonic Systems Inc |
| Jul 27, 2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - ... | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... | Class II | Sunrise Medical (US) LLC |
| Jul 27, 2015 | Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Ma... | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... | Class II | Trumpf Medical Systems, Inc. |
| Jul 24, 2015 | cobas Liat Analyzer, for in vitro diagnostic use. | Due to a supplier issue, the incorrect green and amber LED components were used in the manufactur... | Class II | Roche Molecular Systems, Inc. |
| Jul 24, 2015 | Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... | EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. | Class II | Medtronic Perfusion Systems |
| Jul 23, 2015 | Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a... | The software is unable to accurately determine the calcium score of scans with a slice thickness ... | Class II | Merge Healthcare, Inc. |
| Jul 23, 2015 | Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems | Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruct... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 23, 2015 | Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response Sy... | Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. | Class II | Lifeline Systems, Incorporated |
| Jul 23, 2015 | Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product... | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 22, 2015 | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Mod... | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft in... | Class II | Biomet Spine, LLC |
| Jul 22, 2015 | COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. ... | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... | Class II | Beckman Coulter Inc. |
| Jul 22, 2015 | COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the abil... | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... | Class II | Beckman Coulter Inc. |
| Jul 22, 2015 | Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... | Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... | Class II | Medtronic MiniMed Inc. |
| Jul 22, 2015 | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... | Due to a manufacturing defect, there is the possibility that a small wire could extend through th... | Class II | Volcano Corporation |
| Jul 22, 2015 | Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A ra... | If arm is not fastened securely it could fall down. | Class II | Philips Electronics North America Corporation |
| Jul 22, 2015 | Synthes Application Instrument for Sternal ZIPFIX; indications for use includ... | The end cap may loosen and detach making the instrument non-functional. No injuries reported. | Class II | Synthes (USA) Products LLC |
| 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 21, 2015 | Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test;... | The devices that included the OVAR research test were not cleared for marketing and mTBI research... | Class II | Neuro Kinetics, Inc. |
| Jul 21, 2015 | CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008;... | These screws have a potential of passing through the plate in the case when torque is applied in ... | Class II | Wright Medical Technology, 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.