Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Mar 16, 2018 GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018 Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnos... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a ... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic devi... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems M... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Mod... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic devic... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 16, 2018 Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... The product label has missing information, such as the lot number and expiration date, as well as... Class II Nobel Biocare Usa Llc
Mar 15, 2018 LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipola... Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged de... Class II Covidien LLC
Mar 15, 2018 Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 Normed Charcot Osteotome Chisel (Various sizes) Product may contain a gap between the handle and metal chisel which can lead to failure to proper... Class II Zimmer GmbH
Mar 15, 2018 Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 ... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 Rectal Catheters; Product Code Equivalent Code 580114 580114 ... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 15, 2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... Class II Biocare Medical, LLC
Mar 15, 2018 Simplastic Suprapubic Puncture Instruments: Product Code Equivalent... These products contain latex, but the following statement is not included on any level of product... Class II Teleflex Medical Europe Ltd
Mar 14, 2018 FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RF... There is an increased risk of false positive Proteus results when the product is used with specif... Class II BioFire Diagnostics, LLC
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Mar 14, 2018 PTS Panels¿ CHOL+GLU Test Strips (REF 1765) Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated s... Class II Polymer Technology Systems, Inc.
Mar 14, 2018 Philips HeartStart (HS1) Onsite/Home AED An issue with one of the electric components (a resistor) could result in the device not deliveri... Class II Philips Electronics North America Corp.
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L:... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Di... Class II Invivo Corporation
Mar 14, 2018 ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... The cap on the vial might be labeled with the incorrect part number but the main vial label is co... Class II Implant Direct Sybron Manufacturing, LLC
Mar 14, 2018 Philips HeartStart FRx AED. An issue with one of the electric components (a resistor) could result in the device not deliveri... Class II Philips Electronics North America Corp.
Mar 14, 2018 Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Ac... The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus ident... Class II Accelerate Diagnostics Inc
Mar 14, 2018 Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen m... After continuous operation for more than one and a half days, the image on the large screen monit... Class II Philips Electronics North America Corporation
Mar 13, 2018 Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical ... Class II Medtronic Sofamor Danek USA Inc
Mar 13, 2018 Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... Class II LivaNova USA
Mar 13, 2018 Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... Class II LivaNova USA
Mar 13, 2018 Genesis Surgical Cassette Tapered Implants are intended for placement fo... The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental bur... Class II Keystone Dental Inc
Mar 13, 2018 Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F ... The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, r... Class II Medtronic Vascular
Mar 12, 2018 Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adul... After two and a half years, the battery fuel gauge may indicate a higher battery charge than what... Class II Hamilton Medical AG
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... Incorrect calibrator level listed in qualitative calibration steps Class III Siemens Healthcare Diagnostics, Inc.
Mar 12, 2018 Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product ... Final quality control testing was not completed before the devices were distributed.. Class II Ohio Medical Corporation
Mar 12, 2018 Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... This device was mislabeled and is not the correct component for this patient. Class II TMJ Solutions Inc
Mar 12, 2018 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c... Products have been packaged with the wrong Trocar length type. Class II CooperSurgical, Inc.
Mar 12, 2018 Phoenix Nail System, intended for use with an intramedullary nail system for ... Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to repor... Class II Zimmer Biomet, Inc.
Mar 12, 2018 Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 076... The power load floor plates which hold the ambulance cot anchors in place during patient transpor... Class II Stryker Medical Division of Stryker Corporation
Mar 12, 2018 Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 Products have been packaged with an incorrect product size. Class II CooperSurgical, Inc.
Mar 12, 2018 McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological mo... Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monit... Class II McKesson Israel Ltd.
Mar 12, 2018 Trident Endoscopic Ultrasonic Aspiration Needle (FNA) The combination of the firmness of the mass, the potential endoscope and elevator position combin... Class II Micro-Tech (Nanjing) Co., Ltd.
Mar 12, 2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... Class II Stryker GmbH
Mar 12, 2018 Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adul... After two and a half years, the battery fuel gauge may indicate a higher battery charge than what... Class II Hamilton Medical AG
Mar 12, 2018 Trident Endoscopic Ultrasonic Biopsy Needle (FNB) The combination of the firmness of the mass, the potential endoscope and elevator position combin... Class II Micro-Tech (Nanjing) Co., Ltd.
Mar 11, 2018 RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endosc... Tube ends may be mixed up. Class II Richard Wolf GmbH
Mar 9, 2018 Proclaim DRG Implantable Pulse Generator, Model Number 3664 The firm received complaints of error messages that occurred during routine impedance checks on P... Class II St. Jude Medical, Inc.
Mar 9, 2018 6376 M-1 Cot Fastener, catalog no. 6376000000 The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... Class II Stryker Medical Division of Stryker Corporation
Mar 9, 2018 Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is ... An out of specification component on the control board may cause the ventilator to open the inspi... Class II Hamilton Medical AG

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.