Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
X Spine Systems Inc
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are s...
Surgical Devices·5 affected·Jul 11, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary Syst...
Surgical Devices·8,638 affected·Jul 10, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary Syste...
Surgical Devices·8,638 affected·Jul 10, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary Syste...
Surgical Devices·8,638 affected·Jul 10, 2014
RecallFDA
Teleflex Medical
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Surgical Devices·720 affected·Jul 10, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Surgical Devices·28,752 affected·Jul 9, 2014
High RiskFDA
Coopersurgical, Inc.
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Surgical Devices·1,400 affected·Jul 3, 2014
High RiskFDA
Steris Corporation
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all gen...
Surgical Devices·3,689 affected·Jun 27, 2014
High RiskFDA
Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated...
Surgical Devices·22,190 affected·Jun 25, 2014
High RiskFDA
Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without...
Surgical Devices·4,976 affected·Jun 25, 2014
High RiskFDA
Bard Access Systems
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Surgical Devices·51,025 affected·Jun 24, 2014
High RiskFDA
Cordis Corporation
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Surgical Devices·250,000 affected·Jun 23, 2014
High RiskFDA
Laser Peripherals Llc
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surg...
Surgical Devices·25 affected·Jun 20, 2014
High RiskFDA
Aesculap, Inc.
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the bo...
Surgical Devices·11 affected·Jun 13, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to...
Surgical Devices·1,250 affected·Jun 11, 2014
High RiskFDA
Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Surgical Devices·19 affected·Jun 11, 2014
High RiskFDA
Pioneer Surgical Technology, Inc.
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabil...
Surgical Devices·5 affected·Jun 11, 2014
High RiskFDA
Argon Medical Devices, Inc
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (3...
Surgical Devices·3,783 affected·Jun 5, 2014
High RiskFDA
Argon Medical Devices, Inc
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) ...
Surgical Devices·3,783 affected·Jun 5, 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·29 affected·Jun 4, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgica...
Surgical Devices·10,467 affected·Jun 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf...
Surgical Devices·814 affected·Jun 3, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Man...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Steril...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM L...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Leng...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as...
Surgical Devices·8,580 affected·May 27, 2014
High RiskFDA
Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instr...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic I...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic In...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Inst...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical En...
Surgical Devices·2,014 affected·May 21, 2014
CriticalFDA
Customed, Inc
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LI...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND C...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAN...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90...
Surgical Devices·32 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPO...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F ...
Surgical Devices·27 affected·May 20, 2014
CriticalFDA
Customed, Inc
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAU...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF ...
Surgical Devices·4 affected·May 20, 2014