FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 12, 2026. New recalls appear here on the FDA's own publishing schedule.

59,160 recall(s)

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1051-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1052-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1053-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1054-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1055-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1056-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1057-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1058-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1059-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1060-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1061-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1062-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1063-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 19, 2024

KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123

Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Root cause: Labeling Change Control

Recalling firm: Karl Storz EndoscopyType: Ureteroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution.Recall #Z-1064-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Dec 15, 2024

Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

Reason: Complaints have been received regarding post-operative implant collapse.

Root cause: Under Investigation by firm

Open, ClassifiedPosted Jan 30, 2025·Initiated Jan 14, 2025

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Reason: Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

Root cause: Device Design

Recalling firm: Draeger Medical Systems, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, NE, NY, OK, PA, SD, TN, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kenya, Malaysia, Mexico, Monaco, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Samoa, American, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkiye, United Kingdom.Recall #Z-1066-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Jan 3, 2025

Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Root cause: Device Design

Recalling firm: LivaNova USA, Inc.Type: Stimulator, Autonomic Nerve, Implanted For EpilepsyDistribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR,PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT and the countries of AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN,IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Luxembourg, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, UAE, United Kingdom.Recall #Z-1067-2025

Open, ClassifiedPosted Jan 30, 2025·Initiated Jan 3, 2025

Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Root cause: Device Design

Open, ClassifiedPosted Jan 30, 2025·Initiated Apr 22, 2024

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Reason: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

Root cause: Software design

Recalling firm: Murata Vios, Inc.Type: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Distribution: Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.Recall #Z-1069-2025

Open, ClassifiedPosted Jan 29, 2025·Initiated Jan 2, 2025

ARTIS One Angiographic X-Ray System

Reason: A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: SIEMENS MEDICAL SOLUTIONS USA, INCType: Interventional Fluoroscopic X-Ray SystemDistribution: 23 Distributed in the USRecall #Z-0922-2025