FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- BodyGuard Microset, REF: A120-003XS2YV
FDA Device · Class I · 2020-07-22 · Cme America - This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices
FDA Device · Class II · 2020-07-22 · Djo - BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset With Female Luer, REF: A120-160XPSN
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the ske…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard Microset, REF: A100-163XES
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CMExpress Microbore Set, REF: A120-160C
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - BodyGuard BodySet, REF: A120-160SAS
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset with Filter, REF: A100-163XESF
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gap…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CMExpress Microbore Sets, REF: A120-161C
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the ske…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bo…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
FDA Device · Class I · 2020-07-22 · Cme America - BodyGuard Microset, REF: A120-160XSFK
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or ga…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varice…
FDA Device · Class II · 2020-07-22 · Diasorin Molecular - BodyGuard Microset, REF: A120-112XSFK
FDA Device · Class I · 2020-07-22 · Cme America - CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps o…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - CMExpress Microbore Sets, REF: A120-160C2YRV
FDA Device · Class I · 2020-07-22 · Cme America - OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or…
FDA Device · Class II · 2020-07-22 · Skeletal Kinetics - Irix-C Forceps Inserter
FDA Device · Class II · 2020-07-15 · Xtant Medical - uCT 760 System, Computed Tomography X-ray System
FDA Device · Class II · 2020-07-15 · Shanghai United Imaging Healthcare - OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixati…
FDA Device · Class II · 2020-07-15 · Orthopediatrics - EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose
FDA Device · Class II · 2020-07-15 · Philips North America - Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the f…
FDA Device · Class II · 2020-07-15 · Laborie Medical Technologies Canada Ulc - COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
FDA Device · Class II · 2020-07-15 · Coopersurgical - DABRA Laser (RA-308 Excimer Laser)
FDA Device · Class II · 2020-07-15 · Ra Medical Systems - RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D.…
FDA Device · Class II · 2020-07-15 · Teleflex Medical - Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MM…
FDA Device · Class II · 2020-07-15 · Philips North America - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - Azure S DR MRI, Model Number W3DR01
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as…
FDA Device · Class II · 2020-07-15 · Fhc - PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approa…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960
FDA Device · Class II · 2020-07-15 · Centurion Medical Products - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients wi…
FDA Device · Class II · 2020-07-15 · Cardinal Health 200 - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the ce…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients wit…
FDA Device · Class II · 2020-07-15 · Cook - Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Co…
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic,…
FDA Device · Class II · 2020-07-15 · Cardinal Health 200 - Blood gases (PCO2, PO2) and blood pH test system
FDA Device · Class II · 2020-07-15 · Radiometer Medical Aps - Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit wit…
FDA Device · Class II · 2020-07-15 · Bound Tree Medical - PORT-A-CATH¿ II POWER P.A.C. Low Profile" system
FDA Device · Class II · 2020-07-15 · Smiths Medical Asd - Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308
FDA Device · Class II · 2020-07-15 · Ctl Medical - OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixati…
FDA Device · Class II · 2020-07-15 · Orthopediatrics - CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307
FDA Device · Class II · 2020-07-15 · Ctl Medical - Extra corporeal circuit with bio-active surface
FDA Device · Class II · 2020-07-15 · Medtronic Perfusion Systems - Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907
FDA Device · Class II · 2020-07-15 · Ctl Medical - Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Azure S SR MRI, Model Number W3SR01
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Blood gases (PCO2, PO2) and blood pH test system
FDA Device · Class II · 2020-07-15 · Radiometer Medical Aps - Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - TOMTEC-ARENA TTA2;software version no. 2.20 and lower
FDA Device · Class II · 2020-07-15 · Tomtec Imaging Systems - CareLink SmartSync Device Manager, Model Number 24970A
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the ce…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908
FDA Device · Class II · 2020-07-15 · Ctl Medical - DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical proc…
FDA Device · Class II · 2020-07-15 · Dufner Instrumente - PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approa…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approa…
FDA Device · Class II · 2020-07-15 · Tedan Surgical Innovations - The CapsoCam Plus (SV-3)
FDA Device · Class II · 2020-07-15 · Capso Vision - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - ACTIV.A.C Therapy System
FDA Device · Class II · 2020-07-15 · Kci Usa - GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch…
FDA Device · Class I · 2020-07-15 · Verathon - Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58…
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
FDA Device · Class II · 2020-07-15 · Prodimed Plastimed Division - Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult a…
FDA Device · Class II · 2020-07-15 · Shanghai United Imaging Healthcare - TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Pr…
FDA Device · Class II · 2020-07-15 · Abbott - Patient Connector, Model Number 24967
FDA Device · Class II · 2020-07-15 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - VistaSolution, physiological signal transmitter
FDA Device · Class II · 2020-07-15 · Vitalconnect - Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes
FDA Device · Class II · 2020-07-15 · Kentec Medical - CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile
FDA Device · Class II · 2020-07-08 · Codan Us - VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask
FDA Device · Class II · 2020-07-08 · Westmed - Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
FDA Device · Class II · 2020-07-08 · Livanova Usa - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
FDA Device · Class I · 2020-07-08 · Arrow International - Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
FDA Device · Class I · 2020-07-08 · Arrow International - Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
FDA Device · Class II · 2020-07-08 · Ortho Organizers - VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
FDA Device · Class II · 2020-07-08 · Ortho Clinical Diagnostics - Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel
FDA Device · Class II · 2020-07-08 · Livanova Deutschland - Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
FDA Device · Class II · 2020-07-08 · Baxter Healthcare - Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use…
FDA Device · Class II · 2020-07-08 · Siemens Healthcare Diagnostics
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)