FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237
FDA Device · Class II · 2022-09-21 · Philips Medical Systems Cleveland - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - ZAP-X Radiosurgery System
FDA Device · Class II · 2022-09-21 · Zap Surgical Systems - Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403
FDA Device · Class I · 2022-09-21 · Baxter Healthcare - Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N
FDA Device · Class III · 2022-09-21 · Microbiologics - QIAcube Connect MDx, Model No. 9003070
FDA Device · Class II · 2022-09-21 · Qiagen Sciences - Surpria: Software Version V3.11, V3.22
FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518
FDA Device · Class II · 2022-09-21 · Cook - iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the read…
FDA Device · Class II · 2022-09-21 · Alcor Scientific - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile
FDA Device · Class II · 2022-09-21 · Technomed Europe - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - GXL acetabular liners, orthopedic hip implant component
FDA Device · Class II · 2022-09-21 · Exactech - Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162
FDA Device · Class II · 2022-09-21 · Cook - VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
FDA Device · Class II · 2022-09-14 · Stradis Healthcare - Optima Coil System Model OPTI0520CSF10
FDA Device · Class II · 2022-09-14 · Balt Usa - Various eye packs, cataract packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various ENT Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
FDA Device · Class II · 2022-09-14 · Datascope - Various Angiography packs/trays
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various hysterectomy, vaginal packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various C-section packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
FDA Device · Class II · 2022-09-14 · Orthopediatrics - MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Device · Class II · 2022-09-14 · Datascope - Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S
FDA Device · Class II · 2022-09-14 · Icu Medical - D&C pack
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various Angiography/Cath Lab packs/trays
FDA Device · Class II · 2022-09-14 · American Contract Systems - Breast Abdominoplasty Pack
FDA Device · Class II · 2022-09-14 · American Contract Systems - Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Device · Class II · 2022-09-14 · Datascope - Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - Philips BiPAP V30 Auto, Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - Various ob/gyn packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Philips BiPAP A30, Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - Various convenience packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various Laparoscopy Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various neurology packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various Pacemaker Packs, Cardio Thoracic Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
FDA Device · Class II · 2022-09-14 · Ortho Clinical Diagnostics - VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
FDA Device · Class II · 2022-09-14 · Ortho Clinical Diagnostics - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster - Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
FDA Device · Class II · 2022-09-14 · Saranas - Various PICC Line, Central Line Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in…
FDA Device · Class II · 2022-09-14 · Merchsource - Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10
FDA Device · Class II · 2022-09-14 · Icu Medical - Philips BiPAP A40, Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - Various Port Insertion Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Various convenience packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use
FDA Device · Class II · 2022-09-14 · Abbott Molecular - Various Cysto Packs
FDA Device · Class II · 2022-09-14 · American Contract Systems - Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - Medline CHEST TUBE REORDER NO: DYNJ36762A
FDA Device · Class II · 2022-09-14 · Medline Industries - Philips OmniLab Advanced+, Rx Only
FDA Device · Class I · 2022-09-14 · Philips Respironics - The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse gene…
FDA Device · Class II · 2022-09-07 · Boston Scientific - Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Device · Class II · 2022-09-07 · Siemens Medical Solutions Usa - DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
FDA Device · Class II · 2022-09-07 · Deroyal Industries - NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
FDA Device · Class I · 2022-09-07 · Medtronic Xomed - ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
FDA Device · Class II · 2022-09-07 · Abbott Laboratories - EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Device · Class II · 2022-09-07 · Medtronic - TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800
FDA Device · Class II · 2022-09-07 · Corin - AIM-V Medium REF AV.200/500
FDA Device · Class II · 2022-09-07 · Oxford Immunotec - DigitalDiagnost C50 1.1
FDA Device · Class II · 2022-09-07 · Philips North America - T-Cell Xtend REF TTK.610 US
FDA Device · Class II · 2022-09-07 · Oxford Immunotec - therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
FDA Device · Class II · 2022-09-07 · Qiagen Sciences - AggreGuide A-100 Instrument
FDA Device · Class II · 2022-09-07 · Aggredyne - INFX-8000V. For radiographic and fluoroscopic studies and intervention
FDA Device · Class II · 2022-09-07 · Canon Medical System Usa - The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse gene…
FDA Device · Class II · 2022-09-07 · Boston Scientific - Pentacam HR REF 70900
FDA Device · Class II · 2022-09-07 · Oculus Optikgeraete - Pentacam AXL REF 70100, Pentacam HR REF 70900
FDA Device · Class II · 2022-09-07 · Oculus Optikgeraete - Artis pheno- Model No. 10849000
FDA Device · Class II · 2022-09-07 · Siemens Medical Solutions Usa - Pentacam AXL Wave REF 70020
FDA Device · Class II · 2022-09-07 · Oculus Optikgeraete - Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and…
FDA Device · Class II · 2022-09-07 · Aesculap Implant Systems - Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283…
FDA Device · Class II · 2022-09-07 · Siemens Medical Solutions Usa - NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
FDA Device · Class I · 2022-09-07 · Medtronic Xomed - VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
FDA Device · Class II · 2022-09-07 · Biomerieux - T-SPOT.TB REF TB.300 US
FDA Device · Class II · 2022-09-07 · Oxford Immunotec - Dimension Vista LOCI CA 15-3 Flex reagent cartridge
FDA Device · Class II · 2022-09-07 · Siemens Healthcare Diagnostics - NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
FDA Device · Class I · 2022-09-07 · Medtronic Xomed - Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System
FDA Device · Class II · 2022-09-07 · New Standard Device - The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Sci…
FDA Device · Class II · 2022-09-07 · Boston Scientific - therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
FDA Device · Class II · 2022-09-07 · Qiagen Sciences - FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
FDA Device · Class II · 2022-09-07 · Qiagen Sciences - The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to comp…
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H…
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tes…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. ABX PENTRA CREATININE 120CP JAFFE 120/130
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile
FDA Device · Class II · 2022-08-31 · Wright Medical Technology - COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Device · Class II · 2022-08-31 · Boston Scientific - B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Device · Class II · 2022-08-31 · Mizuho Osi - BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
FDA Device · Class II · 2022-08-31 · Nobel Biocare
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)