FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anat…
FDA Device · Class II · 2023-08-09 · Olympus - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means…
FDA Device · Class II · 2023-08-09 · Scican - ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in ma…
FDA Device · Class II · 2023-08-09 · Materialise N V - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - OEC 9800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems - Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and…
FDA Device · Class II · 2023-08-09 · Zimmer - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Incisive CT-Computed Tomography X-Ray System Model: 728143
FDA Device · Class II · 2023-08-09 · Philips North America - Allura Xper FD10 and FD20
FDA Device · Class II · 2023-08-09 · Philips Medical Systems Nederland B V - HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and ne…
FDA Device · Class I · 2023-08-02 · Hamilton Medical - HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and option…
FDA Device · Class I · 2023-08-02 · Hamilton Medical - TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Pa…
FDA Device · Class II · 2023-08-02 · Datascope - LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
FDA Device · Class II · 2023-08-02 · Datascope - VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only
FDA Device · Class III · 2023-08-02 · Ortho Clinical Diagnostics - Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system…
FDA Device · Class II · 2023-08-02 · Davol - Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser co…
FDA Device · Class II · 2023-08-02 · Boston Scientific - SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Desc…
FDA Device · Class II · 2023-08-02 · Datascope - vRad PACS with Mammography
FDA Device · Class II · 2023-08-02 · Virtual Radiologic - Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser console…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser c…
FDA Device · Class II · 2023-08-02 · Boston Scientific - MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Pa…
FDA Device · Class II · 2023-08-02 · Datascope - A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application
FDA Device · Class II · 2023-08-02 · Medtronic Neuromodulation - Ringed DxI Reaction Vessels (RVs)
FDA Device · Class II · 2023-08-02 · Beckman Coulter - FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRE…
FDA Device · Class II · 2023-08-02 · Microvention - REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product De…
FDA Device · Class II · 2023-08-02 · Datascope - SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Des…
FDA Device · Class II · 2023-08-02 · Datascope - DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
FDA Device · Class II · 2023-08-02 · Medline Industries Northfield - YAMATO PLUS IAB
FDA Device · Class II · 2023-08-02 · Datascope - QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the follow…
FDA Device · Class II · 2023-08-02 · Qiagen - HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatr…
FDA Device · Class I · 2023-08-02 · Hamilton Medical - Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly…
FDA Device · Class II · 2023-08-02 · Argon Medical Devices - HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally inf…
FDA Device · Class I · 2023-08-02 · Hamilton Medical - Trexo Device
FDA Device · Class II · 2023-08-02 · Trexo Robotics Holdings - SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descript…
FDA Device · Class II · 2023-08-02 · Datascope - Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Singl…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning syst…
FDA Device · Class II · 2023-08-02 · Davol - Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sy…
FDA Device · Class II · 2023-08-02 · Davol - QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients sus…
FDA Device · Class II · 2023-08-02 · Qiagen - Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles t…
FDA Device · Class II · 2023-08-02 · Boston Scientific - MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
FDA Device · Class II · 2023-08-02 · Datascope - Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
FDA Device · Class II · 2023-08-02 · Davol - QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasoph…
FDA Device · Class II · 2023-08-02 · Qiagen - Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pedia…
FDA Device · Class II · 2023-08-02 · Siemens Medical Solutions Usa - Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
FDA Device · Class I · 2023-07-26 · Olympus - Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
FDA Device · Class I · 2023-07-26 · Olympus - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
FDA Device · Class I · 2023-07-26 · Abiomed - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-07-26 · Datascope - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
FDA Device · Class II · 2023-07-26 · Aesculap Implant Systems - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS98306…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MN…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
FDA Device · Class II · 2023-07-26 · Digisonics - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-4011…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-4013…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100
FDA Device · Class II · 2023-07-26 · Medtronic Neurosurgery - Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Device · Class II · 2023-07-26 · Beckman Coulter Biomedical - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Device · Class I · 2023-07-26 · Abiomed - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Aeris Balloon Dilation Catheter
FDA Device · Class II · 2023-07-26 · Bryan Medical - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Device · Class I · 2023-07-26 · Abiomed - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct…
FDA Device · Class II · 2023-07-26 · Diasorin Molecular - Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Device · Class I · 2023-07-26 · Abiomed - NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
FDA Device · Class II · 2023-07-26 · Cardinal Health 200 - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of te…
FDA Device · Class II · 2023-07-26 · Ufsk International Osys - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultra…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - GEM FLOW COUPLER Monitor, PN 5156-00000-011
FDA Device · Class II · 2023-07-26 · Baxter Healthcare - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Device · Class II · 2023-07-26 · Beckman Coulter Biomedical - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Nu…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - RET Distal Probe
FDA Device · Class II · 2023-07-26 · Cytocell - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield
Other years
2026 (2,024) · 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)