FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022
FDA Device · Class II · 2021-06-09 · Zavation - NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
FDA Device · Class II · 2021-06-09 · Marvao Medical Devices - The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extra…
FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems - InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIK…
FDA Device · Class II · 2021-06-09 · Zavation - 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery
FDA Device · Class II · 2021-06-09 · Meta C G M Spa - ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11
FDA Device · Class II · 2021-06-09 · Zavation - Multitom RAX with software version VF10
FDA Device · Class II · 2021-06-09 · Siemens Medical Solutions Usa - Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated…
FDA Device · Class II · 2021-06-09 · K2m - VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10
FDA Device · Class II · 2021-06-09 · Zavation - Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or lo…
FDA Device · Class II · 2021-06-09 · Draeger Medical - Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixati…
FDA Device · Class II · 2021-06-09 · Zimmer - Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated…
FDA Device · Class II · 2021-06-09 · K2m - Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen S…
FDA Device · Class I · 2021-06-09 · Lepu Medical Technology Beijing - 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or I…
FDA Device · Class I · 2021-06-09 · Lepu Medical Technology Beijing - ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11
FDA Device · Class II · 2021-06-09 · Zavation - 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG
FDA Device · Class II · 2021-06-09 · Medtronic Minimed - ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer
FDA Device · Class II · 2021-06-09 · Clinical Laserthermia Systems Ab - ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant
FDA Device · Class II · 2021-06-09 · Signature Orthopedics - 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25…
FDA Device · Class II · 2021-06-09 · Flower Orthopedics - 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery
FDA Device · Class II · 2021-06-09 · Meta C G M Spa - ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS
FDA Device · Class II · 2021-06-09 · Vygon U - InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
FDA Device · Class II · 2021-06-09 · Getinge Suzhou - The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for b…
FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems - BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body
FDA Device · Class II · 2021-06-09 · Philips North America - 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and…
FDA Device · Class II · 2021-06-09 · Change Healthcare Canada - 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures
FDA Device · Class II · 2021-06-09 · Zavation - NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic…
FDA Device · Class II · 2021-06-02 · Nobel Biocare Procera - BiPAP A40, China: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically meas…
FDA Device · Class II · 2021-06-02 · Welch Allyn - Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dial…
FDA Device · Class II · 2021-06-02 · Baxter Healthcare - PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collect…
FDA Device · Class II · 2021-06-02 · Radiometer Medical Aps - BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator
FDA Device · Class II · 2021-06-02 · Coopersurgical - GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings
FDA Device · Class II · 2021-06-02 · Welch Allyn - Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
FDA Device · Class II · 2021-06-02 · Beckman Coulter - IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monit…
FDA Device · Class II · 2021-06-02 · Philips North America - NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prostheti…
FDA Device · Class II · 2021-06-02 · Nobel Biocare Procera - BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prostheti…
FDA Device · Class II · 2021-06-02 · Nobel Biocare Procera - Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment
FDA Device · Class II · 2021-06-02 · Dentech - VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection…
FDA Device · Class II · 2021-06-02 · Ortho Clinical Diagnostics - Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Tre…
FDA Device · Class II · 2021-06-02 · Siemens Healthcare Diagnostics - MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device
FDA Device · Class II · 2021-06-02 · James Leckey Design - NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prostheti…
FDA Device · Class II · 2021-06-02 · Nobel Biocare Procera - NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prostheti…
FDA Device · Class II · 2021-06-02 · Nobel Biocare Procera - BiPAP A40, Brazil: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - BiPAP A30, Brazil: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide opt…
FDA Device · Class II · 2021-06-02 · Pentax - IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative dete…
FDA Device · Class II · 2021-06-02 · Roche Diagnostics Operations - BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting
FDA Device · Class II · 2021-06-02 · Philips Respironics - REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 007…
FDA Device · Class II · 2021-05-26 · Medtronic - REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for us…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000…
FDA Device · Class II · 2021-05-26 · Medtronic - GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts
FDA Device · Class II · 2021-05-26 · W L Gore And Associates - Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: i…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GT…
FDA Device · Class II · 2021-05-26 · Medtronic - REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of sympt…
FDA Device · Class I · 2021-05-26 · Boston Scientific - Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use…
FDA Device · Class II · 2021-05-26 · Medtronic - REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for us…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 207…
FDA Device · Class II · 2021-05-26 · Medtronic - BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI:…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)108…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1080…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction
FDA Device · Class II · 2021-05-26 · Roche Diagnostics Operations
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)