Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Produ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urologica...
Surgical Devices·14 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Cathet...
Surgical Devices·4,910 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are us...
Surgical Devices·59,089 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Cat...
Surgical Devices·22,380 affected·Mar 28, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature...
Surgical Devices·1,038 affected·Mar 22, 2013
High RiskFDA
Intuitive Surgical, Inc.
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes prot...
Surgical Devices·1,642 affected·Mar 15, 2013
High RiskFDA
Intuitive Surgical, Inc.
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Surgical Devices·1,642 affected·Mar 15, 2013
High RiskFDA
Synvasive Technology Inc
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. ...
Surgical Devices·100 affected·Mar 14, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange du...
Surgical Devices·225 affected·Mar 13, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. ...
Surgical Devices·27,682 affected·Mar 13, 2013
High RiskFDA
Hospira Inc.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ...
Surgical Devices·53,151 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partu...
Surgical Devices·8,216 affected·Mar 8, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical site...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera t...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the...
Surgical Devices·54 affected·Mar 5, 2013
High RiskFDA
Hill-rom, Inc.
TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not ...
Surgical Devices·309 affected·Feb 26, 2013
RecallFDA
Cooper Surgical, Inc.
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into th...
Surgical Devices·175 affected·Feb 26, 2013
RecallFDA
Cooper Surgical, Inc.
Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is i...
Surgical Devices·45 affected·Feb 26, 2013
High RiskFDA
Cooper Surgical, Inc.
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to ...
Surgical Devices·4,395 affected·Feb 26, 2013
CriticalFDA
Symbios Medical Products, Llc
GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump com...
Surgical Devices·458 affected·Feb 25, 2013
High RiskFDA
Baxter Healthcare Corp.
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapt...
Surgical Devices·1,213,833 affected·Feb 25, 2013
High RiskFDA
Baxter Healthcare Corp.
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dial...
Surgical Devices·33,474 affected·Feb 25, 2013
High RiskFDA
Bard Access Systems
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0...
Surgical Devices·73 affected·Feb 21, 2013
High RiskFDA
Bard Access Systems
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric produ...
Surgical Devices·195 affected·Feb 21, 2013
High RiskFDA
Spinal Solutions, Llc
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consi...
Surgical Devices·24 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consign...
Surgical Devices·106 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or ...
Surgical Devices·16 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 ...
Surgical Devices·35 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x...
Surgical Devices·56 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large ...
Surgical Devices·24 affected·Feb 20, 2013
High RiskFDA
Spinal Solutions, Llc
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consign...
Surgical Devices·63 affected·Feb 20, 2013
High RiskFDA
Medicamat S.a.
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
Surgical Devices·71 affected·Feb 18, 2013
High RiskFDA
Elana, Inc.
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA techni...
Surgical Devices·3 affected·Feb 14, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrume...
Surgical Devices·22,500 affected·Feb 12, 2013
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8
Surgical Devices·22 affected·Feb 10, 2013
High RiskFDA
Myco Medical Supplies Inc
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Surgical Devices·110,768 affected·Feb 7, 2013
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operat...
Surgical Devices·53 affected·Feb 5, 2013
High RiskFDA
Cordis Corporation
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Surgical Devices·80 affected·Feb 5, 2013
High RiskFDA
Biomet, Inc.
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Surgical Devices·58 affected·Feb 5, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma...
Surgical Devices·4,000 affected·Feb 5, 2013
High RiskFDA
Arrow International Inc
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Acces...
Surgical Devices·2,480 affected·Feb 4, 2013
High RiskFDA
Salyer Prn Biomedical
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in car...
Surgical Devices·9 affected·Jan 31, 2013
High RiskFDA
Bacterin International, Inc.
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, B...
Surgical Devices·15 affected·Jan 28, 2013
High RiskFDA
Edwards Lifesciences, Llc
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit ...
Surgical Devices·807 affected·Jan 25, 2013
RecallFDA
Linvatec Corp. Dba Conmed Linvatec
D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered inst...
Surgical Devices·23 affected·Jan 24, 2013