FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12
FDA Device · Class II · 2025-02-19 · Cardinal Health 200 - Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341
FDA Device · Class II · 2025-02-12 · Sysmex America - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-02-12 · Fresenius Kabi Usa - AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon - regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - Allura CV20 System Code: 722031
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Azurion 3 M12 System Code: (1) 722063 (2) 722221
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137
FDA Device · Class II · 2025-02-12 · Beckman Coulter - Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709)
FDA Device · Class II · 2025-02-12 · Ge Medical Systems - AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
FDA Device · Class II · 2025-02-12 · Oxoid - Discovery XR656HD. X-Ray imaging system
FDA Device · Class II · 2025-02-12 · Ge Medical Systems - UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software application…
FDA Device · Class II · 2025-02-12 · Medicrea International - Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - IntelliVue Patient Monitor MX550
FDA Device · Class II · 2025-02-12 · Philips North America - AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517
FDA Device · Class II · 2025-02-12 · New Medical Technologies - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon - Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - IntelliVue Patient Monitor MX400
FDA Device · Class II · 2025-02-12 · Philips North America - LIFEPAK 35 ECG cable REF 11111-000041
FDA Device · Class II · 2025-02-12 · Physio Control - IntelliVue Patient Monitor MX500
FDA Device · Class II · 2025-02-12 · Philips North America - Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or al…
FDA Device · Class II · 2025-02-12 · Belmont Instrument - Temporary Titanium Abutments
FDA Device · Class II · 2025-02-12 · Dds Lab - IntelliBridge EC10 Module
FDA Device · Class II · 2025-02-12 · Philips North America - Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP3…
FDA Device · Class II · 2025-02-12 · Neilmed Pharmaceuticals - The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001)
FDA Device · Class II · 2025-02-12 · Hologic - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon - AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK…
FDA Device · Class II · 2025-02-12 · Us Endodontics - IntelliVue Patient Monitor MX450
FDA Device · Class II · 2025-02-12 · Philips North America - Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Discovery XR656 HD. X-Ray imaging system
FDA Device · Class II · 2025-02-12 · Ge Medical Systems - AlluraXperFD20/15 System Code: (1) 722058
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Allura Xper FD10C System Code: (1) 722001
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - AlluraXperFD20/10 System Code: (1) 722029
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Bioca…
FDA Device · Class II · 2025-02-12 · Nobel Biocare - Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
FDA Device · Class II · 2025-02-12 · Beckman Coulter - Azurion 5 M12 System Code: (1) 722227 (2) 722231
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa - Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516
FDA Device · Class II · 2025-02-12 · New Medical Technologies - Optima XR646 HD. X-Ray imaging system
FDA Device · Class II · 2025-02-12 · Ge Medical Systems - AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - Allura Xper FD20/20 System Code: (1) 722038
FDA Device · Class II · 2025-02-12 · Philips Medical Systems Nederland B V - KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Re…
FDA Device · Class II · 2025-02-05 · Medtronic Navigation - KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural s…
FDA Device · Class II · 2025-02-05 · B Braun Medical - AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
FDA Device · Class II · 2025-02-05 · Boston Scientific - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating
FDA Device · Class II · 2025-02-05 · Medline Industries Northfield - ARTIS One Angiographic X-Ray System
FDA Device · Class II · 2025-02-05 · Siemens Medical Solutions Usa - AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
FDA Device · Class II · 2025-02-05 · Boston Scientific - BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 400…
FDA Device · Class II · 2025-02-05 · Carefusion 303 - muRata Vios Monitoring System Model 2050
FDA Device · Class II · 2025-02-05 · Murata Vios - AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Device · Class II · 2025-02-05 · Boston Scientific - KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189
FDA Device · Class II · 2025-02-05 · Medline Industries Northfield - HemosIL Heparin Calibrators
FDA Device · Class II · 2025-02-05 · Instrumentation Laboratory - KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
FDA Device · Class II · 2025-02-05 · Accuray - Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188
FDA Device · Class II · 2025-02-05 · Medline Industries Northfield - KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
FDA Device · Class II · 2025-02-05 · Boston Scientific - NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
FDA Device · Class II · 2025-02-05 · Zimmer - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
FDA Device · Class II · 2025-02-05 · Boston Scientific - CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7
FDA Device · Class II · 2025-02-05 · Medline Industries Northfield - KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
FDA Device · Class II · 2025-02-05 · Boston Scientific - KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
FDA Device · Class II · 2025-02-05 · Boston Scientific - KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - Infinity Central Station
FDA Device · Class II · 2025-02-05 · Draeger Medical Systems - NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
FDA Device · Class II · 2025-02-05 · Zimmer - Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130
FDA Device · Class II · 2025-02-05 · Medline Industries Northfield - AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
FDA Device · Class II · 2025-02-05 · Boston Scientific - Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, no…
FDA Device · Class II · 2025-02-05 · Alphatec Spine - KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600
FDA Device · Class I · 2025-02-05 · Medline Industries Northfield - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
FDA Device · Class II · 2025-02-05 · Boston Scientific - KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
FDA Device · Class II · 2025-02-05 · Boston Scientific - KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
FDA Device · Class II · 2025-02-05 · Boston Scientific - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B
FDA Device · Class I · 2025-02-05 · Medline Industries Northfield - BD Pyxis Med ES Auxiliary (AUX), REF 343
FDA Device · Class II · 2025-01-29 · Carefusion 303 - BD Pyxis MedStation 4000 AUX, REF 306
FDA Device · Class II · 2025-01-29 · Carefusion 303
Other years
2026 (2,088) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)