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.

• Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
  FDA Device · Class II · 2021-06-30 · Medical Action Industries 306
• Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
  FDA Device · Class II · 2021-06-30 · Biofire Diagnostics
• ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For…
  FDA Device · Class II · 2021-06-30 · Smith And Nephew
• Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (0…
  FDA Device · Class II · 2021-06-30 · Biofire Diagnostics
• VAPORIZER VICKS 1.5GAL Item Number: 2354942
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001
  FDA Device · Class II · 2021-06-30 · Ventec Life Systems
• Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• novaplus, General Purpose Kit, Cat
  FDA Device · Class II · 2021-06-30 · Medical Action Industries 306
• Sapi Med sterile disposable colorectal anoscopes and proctoscopes
  FDA Device · Class II · 2021-06-30 · Adler Micromed
• Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
  FDA Device · Class II · 2021-06-30 · Ge Healthcare
• 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• Hays Ultrasound kit Item ID: H1000SE
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• GENOSYL DS
  FDA Device · Class I · 2021-06-30 · Vero Biotech
• FREESTYLE LANCETS 28G 100CT Item Number:2975670
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
  FDA Device · Class II · 2021-06-30 · Exact Medical Manufacturing
• Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sore…
  FDA Device · Class II · 2021-06-30 · Ehob
• Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
  FDA Device · Class II · 2021-06-30 · Beckman Coulter
• DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
  FDA Device · Class II · 2021-06-30 · Cardinal Health
• Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney…
  FDA Device · Class II · 2021-06-23 · Medivators
• Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown…
  FDA Device · Class II · 2021-06-23 · Windstone Medical Packaging
• v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123
  FDA Device · Class II · 2021-06-23 · Abbott Laboratories St Jude Medical
• Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated wi…
  FDA Device · Class I · 2021-06-23 · Medtronic Vascular
• Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory ca…
  FDA Device · Class II · 2021-06-23 · Covidien
• v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-b…
  FDA Device · Class II · 2021-06-23 · Abbott Laboratories St Jude Medical
• Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respir…
  FDA Device · Class II · 2021-06-23 · Covidien
• VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS
  FDA Device · Class II · 2021-06-23 · Bard Peripheral Vascular
• Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gow…
  FDA Device · Class II · 2021-06-23 · Windstone Medical Packaging
• GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (…
  FDA Device · Class II · 2021-06-23 · Ge Healthcare
• Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat scre…
  FDA Device · Class II · 2021-06-23 · Skytron Div The Kmw Group
• VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200m…
  FDA Device · Class II · 2021-06-23 · Bard Peripheral Vascular
• ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear
  FDA Device · Class II · 2021-06-23 · Johnson And Johnson Vision Care
• Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients…
  FDA Device · Class II · 2021-06-23 · Covidien
• Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care pa…
  FDA Device · Class II · 2021-06-23 · Covidien
• Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS
  FDA Device · Class II · 2021-06-23 · Bard Peripheral Vascular
• Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002
  FDA Device · Class II · 2021-06-23 · Corin
• Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• E3800 PC Units (spare parts)
  FDA Device · Class II · 2021-06-23 · Radiometer Medical Aps
• The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits
  FDA Device · Class II · 2021-06-23 · Circulatory Technology
• Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
  FDA Device · Class II · 2021-06-23 · Siemens Healthcare Diagnostics
• Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-…
  FDA Device · Class II · 2021-06-23 · Anodyne Surgical
• Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
  FDA Device · Class II · 2021-06-23 · Abbott Laboratories St Jude Medical
• Radiometer ABL90 FLEX Analyzer with E3800 PC units
  FDA Device · Class II · 2021-06-23 · Radiometer Medical Aps
• Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007
  FDA Device · Class II · 2021-06-23 · Corin
• Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units
  FDA Device · Class II · 2021-06-23 · Radiometer Medical Aps
• Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx
  FDA Device · Class II · 2021-06-23 · Medtronic Perfusion Systems
• OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine
  FDA Device · Class II · 2021-06-23 · Ossur Americas
• DeRoyal Angio Cath Removal Tray, REF 89-9936.02
  FDA Device · Class I · 2021-06-16 · Deroyal Industries
• Quanta System Sterile Optical Laser Fiber, single use
  FDA Device · Class II · 2021-06-16 · Quanta System S P A
• Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
  FDA Device · Class I · 2021-06-16 · Deroyal Industries
• RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 ,…
  FDA Device · Class II · 2021-06-16 · Raysearch Laboratories Ab
• Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03
  FDA Device · Class I · 2021-06-16 · Avid Medical
• Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer
  FDA Device · Class II · 2021-06-16 · Hardy Diagnostics
• FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020
  FDA Device · Class I · 2021-06-16 · Avid Medical
• JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13m…
  FDA Device · Class I · 2021-06-16 · Smiths Medical Asd
• Quanta System Sterile Optical Laser Fiber, reusable
  FDA Device · Class II · 2021-06-16 · Quanta System S P A
• Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
  FDA Device · Class II · 2021-06-16 · Alphatec Spine

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)