Category
Surgical Devices Recalls
3,817 surgical devices recalls on record from CPSC, FDA, and USDA.
3,817 recalls
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Stryker Communications
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensi...
Surgical Devices292 affectedFeb 28, 2017
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Conmed Corporation
Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) c...
Surgical Devices0 affectedFeb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be u...
Surgical Devices1 affectedFeb 27, 2017
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Direct...
Surgical Devices11,360 affectedFeb 15, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Surgical Devices46 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
Surgical Devices247 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52
Surgical Devices608 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
Surgical Devices250 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
Surgical Devices4,673 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Surgical Devices4,673 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
Surgical Devices2,065 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
Surgical Devices403 affectedFeb 7, 2017
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53
Surgical Devices2,065 affectedFeb 7, 2017
High RiskFDA
Cook Inc.
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers a...
Surgical Devices778 affectedFeb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for in...
Surgical Devices884 affectedFeb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended fo...
Surgical Devices854 affectedFeb 1, 2017
High RiskFDA
Synthes (usa) Products Llc
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the ...
Surgical Devices2 affectedJan 31, 2017
High RiskFDA
Covidien Llc
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF...
Surgical Devices42,750 affectedJan 23, 2017
High RiskFDA
Covidien Llc
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conju...
Surgical Devices1,111,600 affectedJan 23, 2017
High RiskFDA
Atrium Medical Corporation
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Surgical Devices660 affectedJan 20, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Surgical Pack, part number PSS3540(A
Surgical Devices88 affectedJan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Newman Surgical Procedure Pack, part number PSS1689(A
Surgical Devices24 affectedJan 11, 2017
High RiskFDA
Aesculap Implant Systems Llc
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Surgical Devices24 affectedJan 9, 2017
High RiskFDA
C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected p...
Surgical Devices755 affectedJan 6, 2017
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to ...
Surgical Devices619 affectedJan 3, 2017
High RiskFDA
Allen Medical Systems, Inc.
Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is int...
Surgical Devices112 affectedJan 3, 2017
High RiskFDA
Ge Oec Medical Systems, Inc
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluo...
Surgical Devices0 affectedDec 19, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001...
Surgical Devices39 affectedDec 15, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Surgical Devices26 affectedDec 13, 2016
High RiskFDA
Bard Access Systems
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips ...
Surgical Devices30,000 affectedDec 9, 2016
High RiskFDA
Bard Access Systems
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a T...
Surgical Devices14,500 affectedDec 9, 2016
High RiskFDA
Cardiovascular Systems Inc
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cath...
Surgical Devices8 affectedDec 7, 2016
High RiskFDA
K2m, Inc
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instrument...
Surgical Devices503 affectedDec 2, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to ...
Surgical Devices1,257 affectedNov 30, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is use...
Surgical Devices1,257 affectedNov 30, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to ...
Surgical Devices1,257 affectedNov 30, 2016
High RiskFDA
Icu Medical, Inc.
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intrava...
Surgical Devices225 affectedNov 30, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove o...
Surgical Devices1,257 affectedNov 30, 2016
High RiskFDA
Symmetry Surgical, Inc.
symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C1813...
Surgical Devices7,613 affectedNov 29, 2016
High RiskFDA
Symmetry Surgical, Inc.
symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856...
Surgical Devices38 affectedNov 29, 2016
High RiskFDA
Teleflex Medical
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Surgical Devices102,843 affectedNov 22, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Dev...
Surgical Devices14 affectedNov 15, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Li...
Surgical Devices82 affectedNov 15, 2016
High RiskFDA
Elana, Inc.
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated fo...
Surgical Devices4 affectedNov 9, 2016
High RiskFDA
Halyard Health, Inc
Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Ful...
Surgical Devices132 affectedNov 9, 2016
High RiskFDA
Olympus Corporation Of The Americas
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Surgical Devices494 affectedNov 3, 2016