FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Polyflux Revaclear Dialyzer, Model Number 110633
FDA Device · Class II · 2014-12-10 · Gambro Renal Products - Wound Closure Tray II, Catalog number 900-064
FDA Device · Class I · 2014-12-10 · Customed - ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONN…
FDA Device · Class I · 2014-12-10 · Conmed - Femoral Pack, Catalog number 900-164
FDA Device · Class I · 2014-12-10 · Customed - Angiography Pack, Catalog number 900-1488
FDA Device · Class I · 2014-12-10 · Customed - Laparotomy Pack, Catalog number 900-176
FDA Device · Class I · 2014-12-10 · Customed - MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG S…
FDA Device · Class I · 2014-12-10 · Conmed - Premium Laparotomy Pack, Catalog number 900-1296
FDA Device · Class I · 2014-12-10 · Customed - The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus
FDA Device · Class II · 2014-12-10 · Aesculap - Peri Gyn Pack, Catalog number 900-1716
FDA Device · Class I · 2014-12-10 · Customed - Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
FDA Device · Class I · 2014-12-10 · Customed - General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…
FDA Device · Class I · 2014-12-10 · Customed - , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc
FDA Device · Class I · 2014-12-10 · Customed - O.R. Towels, Catalog number 900-629
FDA Device · Class I · 2014-12-10 · Customed - Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565
FDA Device · Class I · 2014-12-10 · Customed - Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…
FDA Device · Class I · 2014-12-10 · Customed - Arthroscopy Pack, Catalog number 900-1042
FDA Device · Class I · 2014-12-10 · Customed - Polyflux Revaclear Max Dialyzer, Model Number 110634
FDA Device · Class II · 2014-12-10 · Gambro Renal Products - Laparoscopy Premium Pack, Catalog number 900-1803
FDA Device · Class I · 2014-12-10 · Customed - Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals…
FDA Device · Class I · 2014-12-10 · Customed - Fanfold Drape, Catalog number 900-633
FDA Device · Class I · 2014-12-10 · Customed - Aquapak Adaptor, 028 NEB, INTL, Product No. 403128
FDA Device · Class II · 2014-12-10 · Teleflex Medical - Minor Laparotomy Pack, Catalog number 900-1735
FDA Device · Class I · 2014-12-10 · Customed - Uretheral Catheter Tray, Catalog number 900-278
FDA Device · Class I · 2014-12-10 · Customed - ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE C…
FDA Device · Class I · 2014-12-10 · Conmed - Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture remov…
FDA Device · Class I · 2014-12-10 · Customed - Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture remova…
FDA Device · Class I · 2014-12-10 · Customed - Premium OB Pack, Catalog number 900-1297
FDA Device · Class I · 2014-12-10 · Customed - Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri…
FDA Device · Class I · 2014-12-10 · Customed - Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, i…
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound…
FDA Device · Class I · 2014-12-10 · Customed - Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…
FDA Device · Class I · 2014-12-10 · Customed - Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - Urology Pack, Catalog number 900-1742
FDA Device · Class I · 2014-12-10 · Customed - Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irriga…
FDA Device · Class I · 2014-12-10 · Customed - Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, sut…
FDA Device · Class I · 2014-12-10 · Customed - Basic Pack W/Out Gown, Catalog number 900-345
FDA Device · Class I · 2014-12-10 · Customed - Hip &
FDA Device · Class I · 2014-12-10 · Customed - Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical A…
FDA Device · Class II · 2014-12-10 · Integra Lifesciences - Breat Pack-TPSC, Catalog number 900-3431
FDA Device · Class I · 2014-12-10 · Customed - Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals…
FDA Device · Class I · 2014-12-10 · Customed - ENT Pack, Catalog number 900-1482
FDA Device · Class I · 2014-12-10 · Customed - Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removal…
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy OB GYN Pack, Catalog number 900-1192
FDA Device · Class I · 2014-12-10 · Customed - Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728
FDA Device · Class II · 2014-12-10 · Teleflex Medical - Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, i…
FDA Device · Class I · 2014-12-10 · Customed - Ophtalmic Pack, Catalog number 900-1780
FDA Device · Class I · 2014-12-10 · Customed - Suction Catheter Kit, Catalog number 900-277
FDA Device · Class I · 2014-12-10 · Customed - Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc
FDA Device · Class I · 2014-12-10 · Customed - CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXI…
FDA Device · Class I · 2014-12-10 · Conmed - Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals,…
FDA Device · Class I · 2014-12-10 · Customed - Cesarean Pack, Catalog number 900-1689
FDA Device · Class I · 2014-12-10 · Customed - Peri Gyn Pack, Catalog number 900-1061
FDA Device · Class I · 2014-12-10 · Customed - Universal Pack, Catalog number 900-1587
FDA Device · Class I · 2014-12-10 · Customed - Gown Surgical Fabric Reinforced XL, Catalog number 900-2568
FDA Device · Class I · 2014-12-10 · Customed - Angiodrape Pack, Catalog number 900-002
FDA Device · Class I · 2014-12-10 · Customed - D&C Laparoscopy Pack, Catalog number 900-1476
FDA Device · Class I · 2014-12-10 · Customed - Reyito Urological Pack, Catalog number 900-1460
FDA Device · Class I · 2014-12-10 · Customed - ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE C…
FDA Device · Class I · 2014-12-10 · Conmed - Major Laparotomy Pack, Catalog number 900-036
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Pack, Catalog number 900-474
FDA Device · Class I · 2014-12-10 · Customed - Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, sutur…
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Chole Pack, Catalog number 900-1059
FDA Device · Class I · 2014-12-10 · Customed - Ophtalmic Pack, Catalog number 900-1933
FDA Device · Class I · 2014-12-10 · Customed - Gown Surg Fully Impervious Large, Catalog number 900-2564
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Pack, Catalog number 900-486
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Chole Pack, Catalog number 900-414
FDA Device · Class I · 2014-12-10 · Customed - ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate woun…
FDA Device · Class I · 2014-12-10 · Customed - Wound Management Tray Ill, Catalog number 900-540
FDA Device · Class I · 2014-12-10 · Customed - Arthroscopy Pack, Catalog number 900-1832
FDA Device · Class I · 2014-12-10 · Customed - Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771
FDA Device · Class I · 2014-12-10 · Customed - Umbilical Vessel Catheter Kit, Catalog number 900-1408
FDA Device · Class I · 2014-12-10 · Customed - PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indic…
FDA Device · Class II · 2014-12-10 · Zimmer Cas - Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir…
FDA Device · Class I · 2014-12-10 · Customed - Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate w…
FDA Device · Class I · 2014-12-10 · Customed - Gown Surgical Non Reinforced XXL, Catalog number 900-2566
FDA Device · Class I · 2014-12-10 · Customed - Wound Management Tray Ryder Memorial, Catalog number 900-1456
FDA Device · Class I · 2014-12-10 · Customed - D&C Laparoscopy Pack, Catalog number 900-1496
FDA Device · Class I · 2014-12-10 · Customed - Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE…
FDA Device · Class I · 2014-12-10 · Conmed - Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate…
FDA Device · Class I · 2014-12-10 · Customed - Target 360 Standard 12mm x 30cm
FDA Device · Class II · 2014-12-10 · Stryker Neurovascular - Arthroscopy Pack, Catalog number 900-620
FDA Device · Class I · 2014-12-10 · Customed - Laparoscopy Pack, Catalog number 900-3178
FDA Device · Class I · 2014-12-10 · Customed - Tummy Tuck Pack, Catalog #900-3026 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
FDA Device · Class I · 2014-12-10 · Customed - Urology Pack, Catalog number 900-1521
FDA Device · Class I · 2014-12-10 · Customed - Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the…
FDA Device · Class II · 2014-12-03 · Materialise Usa - Cannulaide, Model 101, 102, 103
FDA Device · Class II · 2014-12-03 · Beevers Manufacturing And Supply - 8MM, CURVED BIPOLAR DISSECTOR
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX De…
FDA Device · Class II · 2014-12-03 · Philips Medical Systems Cleveland - Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion…
FDA Device · Class II · 2014-12-03 · Toshiba American Medical Systems - 8MM, SMALL GRASPING RETRACTOR
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - 8MM, ATRIAL RETRACTOR SHORT RIGHT
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cra…
FDA Device · Class I · 2014-12-03 · Philips Medical Systems - BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
FDA Device · Class II · 2014-12-03 · Philips Medical Systems Cleveland - 8MM PERMANENT CAUTERY SPATULA
FDA Device · Class II · 2014-12-03 · Intuitive Surgical - Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion…
FDA Device · Class II · 2014-12-03 · Toshiba American Medical Systems - GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088
FDA Device · Class II · 2014-12-03 · Hospira - 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatm…
FDA Device · Class II · 2014-12-03 · Zoll Circulation
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)