Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Customed, Inc
Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) TOWEL ABSORBENT 15 X 20 LIF (10) GAUZE SPON...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TO...
Surgical Devices·29 affected·May 20, 2014
High RiskFDA
Integra Lifesciences Corp.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c De...
Surgical Devices·61 affected·May 19, 2014
High RiskFDA
Synthes, Inc.
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instr...
Surgical Devices·44 affected·May 15, 2014
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Surgical Devices·1,180 affected·May 13, 2014
High RiskFDA
Microline Surgical, Inc.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Surgical Devices·6,290 affected·May 12, 2014
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is posi...
Surgical Devices·2 affected·May 9, 2014
CriticalFDA
Conmed Corporation
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical pr...
Surgical Devices·12,600 affected·May 8, 2014
High RiskFDA
Ge Healthcare, Llc
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex S...
Surgical Devices·3,221 affected·May 2, 2014
High RiskFDA
Microport Orthopedics Inc.
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Surgical Devices·140 affected·Apr 30, 2014
High RiskFDA
Cryolife, Inc.
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods...
Surgical Devices·6,190 affected·Apr 25, 2014
High RiskFDA
C P Medical Inc.
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled...
Surgical Devices·4 affected·Apr 23, 2014
High RiskFDA
Aesculap, Inc.
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cere...
Surgical Devices·48 affected·Apr 21, 2014
High RiskFDA
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the s...
Surgical Devices·2,591 affected·Apr 16, 2014
High RiskFDA
Biomet, Inc.
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic inst...
Surgical Devices·100 affected·Apr 15, 2014
High RiskFDA
Cordis Corporation
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate ...
Surgical Devices·98 affected·Apr 15, 2014
High RiskFDA
Microline Surgical
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips a...
Surgical Devices·540 affected·Apr 14, 2014
High RiskFDA
Tenex Health Inc
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the...
Surgical Devices·9,927 affected·Apr 14, 2014
High RiskFDA
Ev3, Inc.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatatio...
Surgical Devices·39 affected·Apr 9, 2014
High RiskFDA
Steris Corporation
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. ...
Surgical Devices·68 affected·Apr 4, 2014
High RiskFDA
Rgi Medical Manufacturing, Inc.
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Surgical Devices·19,200 affected·Mar 28, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smok...
Surgical Devices·35,310 affected·Mar 26, 2014
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Surgical Devices·789 affected·Mar 24, 2014
High RiskFDA
Zimmer, Inc.
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following su...
Surgical Devices·2,222 affected·Mar 19, 2014
High RiskFDA
Zimmer, Inc.
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries ...
Surgical Devices·131 affected·Mar 19, 2014
High RiskFDA
Intervalve Inc
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular proce...
Surgical Devices·2 affected·Mar 14, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Teleflex Medical
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. ...
Surgical Devices·7,380 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Tele...
Surgical Devices·7,380 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approx...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek I...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Medtronic Vascular, Inc.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, St...
Surgical Devices·50 affected·Mar 3, 2014
High RiskFDA
Boston Scientific Corporation
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Surgical Devices·7 affected·Mar 3, 2014
High RiskFDA
Medtronic Vascular, Inc.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, St...
Surgical Devices·50 affected·Mar 3, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venou...
Surgical Devices·0 affected·Mar 3, 2014
High RiskFDA
Biocardia, Inc.
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 ...
Surgical Devices·2,541 affected·Mar 3, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Ven...
Surgical Devices·0 affected·Mar 3, 2014
High RiskFDA
Megadyne Medical Products, Inc.
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester pe...
Surgical Devices·494 affected·Feb 27, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrum...
Surgical Devices·21 affected·Feb 14, 2014
High RiskFDA
Biosense Webster, Inc.
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC ...
Surgical Devices·8 affected·Feb 12, 2014