Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Integra Lifesciences Corporation
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. Th...
Surgical Devices·5 affected·Nov 5, 2012
High RiskFDA
California Medical Laboratories Inc
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Surgical Devices·112,462 affected·Nov 2, 2012
High RiskFDA
California Medical Laboratories Inc
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under ...
Surgical Devices·112,468 affected·Nov 2, 2012
High RiskFDA
Cooper Surgical, Inc.
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endos...
Surgical Devices·1,215 affected·Oct 31, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Surgical Devices·1,315 affected·Oct 10, 2012
High RiskFDA
Ethicon Endo-surgery Inc
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Surgical Devices·5,894,975 affected·Oct 4, 2012
High RiskFDA
Stryker Communications, Inc.
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is p...
Surgical Devices·1,082 affected·Sep 25, 2012
High RiskFDA
Teleflex Medical
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Me...
Surgical Devices·126 affected·Sep 25, 2012
High RiskFDA
Medline Industries Inc
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: Th...
Surgical Devices·18 affected·Sep 20, 2012
High RiskFDA
Trumpf Medical Systems, Inc.
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or e...
Surgical Devices·275 affected·Sep 19, 2012
High RiskFDA
Boston Scientific Corporation
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequenc...
Surgical Devices·19,716 affected·Sep 17, 2012
High RiskFDA
Boston Scientific Corporation
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable,...
Surgical Devices·19 affected·Sep 17, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging S...
Surgical Devices·46 affected·Sep 14, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging Sys...
Surgical Devices·414 affected·Sep 14, 2012
High RiskFDA
C.r. Bard, Inc., Urological Division
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated...
Surgical Devices·4,032 affected·Sep 7, 2012
RecallFDA
Gynex Corporation
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. L...
Surgical Devices·19 affected·Sep 6, 2012
High RiskFDA
Zimmer, Inc.
Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and se...
Surgical Devices·195 affected·Aug 31, 2012
Medium RiskFDA
Viscot Medical Llc
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field du...
Surgical Devices·458,589 affected·Aug 22, 2012
CriticalFDA
Vycor Medical, Inc.
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System...
Surgical Devices·3,000 affected·Aug 21, 2012
CriticalFDA
Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref...
Surgical Devices·28,276 affected·Aug 21, 2012
CriticalFDA
Ethicon, Inc.
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a to...
Surgical Devices·45,200 affected·Aug 21, 2012
High RiskFDA
Abbott Vascular
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Surgical Devices·61,799 affected·Aug 20, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Surgical Specialties Puerto Rico Inc. Dba Angiotech Pr Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Surgical Devices·117,948 affected·Aug 15, 2012
High RiskFDA
Applied Medical Resources Corp
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BI...
Surgical Devices·40,238 affected·Aug 9, 2012
High RiskFDA
Nipro Medical Corporation
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic p...
Surgical Devices·300 affected·Jul 27, 2012
High RiskFDA
Nipro Medical Corporation
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic proc...
Surgical Devices·1,500 affected·Jul 27, 2012
High RiskFDA
Nipro Medical Corporation
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic p...
Surgical Devices·700 affected·Jul 27, 2012
High RiskFDA
Stryker Orthobiologics, Inc.
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare ...
Surgical Devices·3,268 affected·Jul 26, 2012
RecallFDA
Teleflex Medical
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage c...
Surgical Devices·611 affected·Jul 20, 2012
High RiskFDA
Galil Medical, Inc.
Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cry...
Surgical Devices·4 affected·Jul 20, 2012
High RiskFDA
Zimmer, Inc.
00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Comple...
Surgical Devices·212 affected·Jul 18, 2012
High RiskFDA
Zimmer, Inc.
Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly ...
Surgical Devices·185 affected·Jul 18, 2012
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in com...
Surgical Devices·226 affected·Jul 17, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Re...
Surgical Devices·108 affected·Jul 14, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics E...
Surgical Devices·340 affected·Jul 14, 2012
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment f...
Surgical Devices·92,390 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment f...
Surgical Devices·92,390 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from conta...
Surgical Devices·92,390 affected·Jul 13, 2012
High RiskFDA
Intuitive Surgical, Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment ...
Surgical Devices·92,390 affected·Jul 13, 2012
High RiskFDA
Kimberly-clark Corporation
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect...
Surgical Devices·933 affected·Jul 5, 2012
High RiskFDA
Kimberly-clark Corporation
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical...
Surgical Devices·89,856 affected·Jul 5, 2012
High RiskFDA
C.r. Bard, Inc., Urological Division
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for s...
Surgical Devices·56,694 affected·Jun 29, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*...
Surgical Devices·879 affected·Jun 26, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgic...
Surgical Devices·879 affected·Jun 26, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** ...
Surgical Devices·879 affected·Jun 26, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***...
Surgical Devices·879 affected·Jun 26, 2012