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.
- Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole bl…
FDA Device · Class II · 2023-03-22 · Siemens Healthcare Diagnostics - In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac…
FDA Device · Class II · 2023-03-22 · Synthes Usa Products - BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold
FDA Device · Class I · 2023-03-22 · Avanos Medical - BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering ins…
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - Recreo Hair Growth Laser Comb
FDA Device · Class II · 2023-03-22 · Omm Imports - BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold
FDA Device · Class I · 2023-03-22 · Avanos Medical - TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
FDA Device · Class II · 2023-03-22 · Limacorporate S P A - Amicus MNC Apheresis Kit Double Needle
FDA Device · Class II · 2023-03-22 · Fenwal - BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac…
FDA Device · Class II · 2023-03-22 · Synthes Usa Products - Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency…
FDA Device · Class II · 2023-03-22 · Securitas Healthcare - Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N)
FDA Device · Class II · 2023-03-22 · Beckman Coulter - Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200
FDA Device · Class II · 2023-03-22 · Intuitive Surgical - BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellit…
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
FDA Device · Class II · 2023-03-22 · Brainlab Ag - Fusion Bioline Vascular Graft, Part number M00201503046B0
FDA Device · Class II · 2023-03-22 · Maquet Cardiovascular - BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes melli…
FDA Device · Class II · 2023-03-22 · Becton Dickinson And - Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location
FDA Device · Class II · 2023-03-22 · Stryker Medical Division - TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fr…
FDA Device · Class II · 2023-03-22 · Synthes Usa Products - CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma
FDA Device · Class II · 2023-03-15 · Aniara Diagnostica - Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
FDA Device · Class II · 2023-03-15 · Stryker Leibinger And Kg - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75,…
FDA Device · Class I · 2023-03-15 · Datascope - PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue
FDA Device · Class III · 2023-03-15 · Preat - CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO…
FDA Device · Class II · 2023-03-15 · Carefusion 2200 - CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460
FDA Device · Class II · 2023-03-15 · Boston Scientific - CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
FDA Device · Class II · 2023-03-15 · Datascope - epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390…
FDA Device · Class II · 2023-03-15 · Siemens Healthcare Diagnostics - Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillat…
FDA Device · Class II · 2023-03-15 · Heartsine Technologies - CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemody…
FDA Device · Class II · 2023-03-15 · St Jude Medical - Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655
FDA Device · Class II · 2023-03-15 · Diasorin Molecular - Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
FDA Device · Class II · 2023-03-15 · Covidien - Cardiosave Hybrid Intra-Aortic Balloon Pump
FDA Device · Class II · 2023-03-15 · Datascope - Cardiosave Rescue
FDA Device · Class II · 2023-03-15 · Datascope - Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1
FDA Device · Class II · 2023-03-15 · Linet Spol S R O - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Cana…
FDA Device · Class II · 2023-03-15 · Siemens Healthcare Diagnostics - Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P
FDA Device · Class II · 2023-03-15 · Baxter Healthcare - Simplexa COVID-19 Direct, REF: MOL4150
FDA Device · Class II · 2023-03-15 · Diasorin Molecular - LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preserv…
FDA Device · Class II · 2023-03-15 · Letsgetchecked - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-…
FDA Device · Class II · 2023-03-15 · Datascope - Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2
FDA Device · Class II · 2023-03-15 · Sensus Healthcare - Monaco RTP System
FDA Device · Class II · 2023-03-15 · Elekta - Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-5…
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31,…
FDA Device · Class I · 2023-03-15 · Datascope - Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022
FDA Device · Class II · 2023-03-08 · Stryker - SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation,…
FDA Device · Class II · 2023-03-08 · Coltene Whaledent - Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA…
FDA Device · Class II · 2023-03-08 · Covidien - ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
FDA Device · Class II · 2023-03-08 · Wright Medical Technology - Ultracell Wick with 80cc Collection Bag, 20/box
FDA Device · Class II · 2023-03-08 · Beaver Visitec International - EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706
FDA Device · Class II · 2023-03-08 · Encore Medical - MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
FDA Device · Class II · 2023-03-08 · Unetixs Vascular - BEQ-HLS 5050 USA
FDA Device · Class II · 2023-03-08 · Maquet Medical Systems Usa - Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31…
FDA Device · Class II · 2023-03-08 · Covidien - Phoenix mKDR, digital mobile diagnostic x-ray system
FDA Device · Class II · 2023-03-08 · Sedecal - Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
FDA Device · Class II · 2023-03-08 · Carefusion 303 - Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DE…
FDA Device · Class II · 2023-03-08 · Covidien - ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
FDA Device · Class II · 2023-03-08 · Wright Medical Technology - Sit to Stand STS500 Patient Lift
FDA Device · Class II · 2023-03-08 · Med Mizer - Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
FDA Device · Class I · 2023-03-08 · Baxter Healthcare - Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement…
FDA Device · Class II · 2023-03-08 · Covidien - Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2023-03-08 · Coopervision - MYLA comprises AST Filters in conjunction with VITEK MS
FDA Device · Class II · 2023-03-08 · Biomerieux - Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-…
FDA Device · Class II · 2023-03-08 · Covidien - MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
FDA Device · Class II · 2023-03-08 · Unetixs Vascular - Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
FDA Device · Class I · 2023-03-08 · Baxter Healthcare - Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
FDA Device · Class I · 2023-03-08 · Baxter Healthcare - Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2023-03-08 · Coopervision - Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss
FDA Device · Class II · 2023-03-08 · Stryker - Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
FDA Device · Class II · 2023-03-08 · Covidien - Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 C…
FDA Device · Class II · 2023-03-08 · Covidien - MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
FDA Device · Class II · 2023-03-08 · Unetixs Vascular - Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
FDA Device · Class II · 2023-03-08 · Sedecal - Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
FDA Device · Class II · 2023-03-08 · Covidien - Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
FDA Device · Class I · 2023-03-08 · Baxter Healthcare - Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010
FDA Device · Class II · 2023-03-08 · Stryker - MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
FDA Device · Class II · 2023-03-08 · Unetixs Vascular - Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGI…
FDA Device · Class II · 2023-03-08 · Covidien - stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400
FDA Device · Class II · 2023-03-08 · Stryker - DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid…
FDA Device · Class II · 2023-03-08 · Carestream Health - Med-Riser MR600 Patient Lift
FDA Device · Class II · 2023-03-08 · Med Mizer - Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24…
FDA Device · Class II · 2023-03-08 · Covidien - Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile
FDA Device · Class II · 2023-03-08 · Summit Medical - Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 S…
FDA Device · Class II · 2023-03-08 · Covidien - Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2…
FDA Device · Class II · 2023-03-08 · Covidien - CustomEyes kits
FDA Device · Class II · 2023-03-08 · Beaver Visitec International - Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells
FDA Device · Class II · 2023-03-01 · Siemens Healthcare Diagnostics - HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intrave…
FDA Device · Class II · 2023-03-01 · Access Vascular - HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intraven…
FDA Device · Class II · 2023-03-01 · Access Vascular - Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
FDA Device · Class II · 2023-03-01 · Siemens Medical Solutions Usa
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)