Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Djo Surgical
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shel...
Surgical Devices·10 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a...
Surgical Devices·31,250 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ess...
Surgical Devices·4,760 affected·Feb 7, 2014
High RiskFDA
Biocardia, Inc.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas,...
Surgical Devices·11 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ...
Surgical Devices·54,590 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard ca...
Surgical Devices·5,540 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters Th...
Surgical Devices·600 affected·Feb 7, 2014
High RiskFDA
Kci Usa, Inc.
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage t...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surg...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to man...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environ...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
B. Braun Medical, Inc.
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container t...
Surgical Devices·2,357,944 affected·Jan 8, 2014
High RiskFDA
Medtronic Sofamor Danek Usa Inc
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical inst...
Surgical Devices·7 affected·Jan 3, 2014
High RiskFDA
Teleflex Medical
Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Int...
Surgical Devices·17,450 affected·Dec 19, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Ballo...
Surgical Devices·39 affected·Dec 18, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
Surgical Devices·34 affected·Dec 18, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Surgical Devices·38 affected·Dec 18, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steri...
Surgical Devices·2,366 affected·Dec 16, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterili...
Surgical Devices·5,584 affected·Dec 16, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray i...
Surgical Devices·257 affected·Dec 11, 2013
High RiskFDA
Merit Medical Systems, Inc.
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculat...
Surgical Devices·59 affected·Dec 6, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasoni...
Surgical Devices·17,253 affected·Dec 5, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·625 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplas...
Surgical Devices·684 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthropla...
Surgical Devices·638 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·641 affected·Nov 19, 2013
High RiskFDA
Intuitive Surgical, Inc.
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA...
Surgical Devices·15 affected·Nov 15, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems...
Surgical Devices·28 affected·Nov 15, 2013
High RiskFDA
Ansell Sandel Medical Industries Llc
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel...
Surgical Devices·13 affected·Nov 12, 2013
High RiskFDA
Ansell Sandel Medical Industries Llc
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medi...
Surgical Devices·96 affected·Nov 12, 2013
High RiskFDA
Ansell Sandel Medical Industries Llc
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medi...
Surgical Devices·15 affected·Nov 12, 2013
High RiskFDA
Arrow International Inc
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Surgical Devices·166 affected·Nov 8, 2013
High RiskFDA
Materialise Usa Llc
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use On...
Surgical Devices·1 affected·Nov 8, 2013
High RiskFDA
Karl Storz Endoscopy America Inc
Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Surgical Devices·7 affected·Nov 6, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and di...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland a...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and di...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and d...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and di...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ir...
Surgical Devices·0 affected·Nov 4, 2013
High RiskFDA
Stryker Neurovascular
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ir...
Surgical Devices·0 affected·Nov 4, 2013
RecallFDA
Intuitive Surgical, Inc.
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1...
Surgical Devices·161 affected·Oct 21, 2013
CriticalFDA
Codman & Shurtleff, Inc.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial o...
Surgical Devices·7,983 affected·Oct 11, 2013
CriticalFDA
Codman & Shurtleff, Inc.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial ...
Surgical Devices·3,860 affected·Oct 11, 2013