Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Stryker Endoscopy
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and m...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, TROCAR, 12.5MM, PYRAMIDAL TIP, P/N 0250080422. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole prepa...
Surgical Devices·1,130 affected·Nov 12, 2014
High RiskFDA
Cure Medical Llc
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P...
Surgical Devices·192 affected·Nov 11, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement pr...
Surgical Devices·4,555 affected·Nov 10, 2014
High RiskFDA
Arrow International Inc
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous ne...
Surgical Devices·786 affected·Nov 10, 2014
High RiskFDA
Csa Medical
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a ...
Surgical Devices·46 affected·Nov 10, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replaceme...
Surgical Devices·3,861 affected·Nov 10, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with ...
Surgical Devices·7,944 affected·Nov 10, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Surgical Devices·31 affected·Nov 6, 2014
High RiskFDA
Abbott Medical Optics Inc (amo)
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging...
Surgical Devices·484,881 affected·Nov 6, 2014
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especi...
Surgical Devices·12 affected·Nov 6, 2014
CriticalFDA
Bausch & Lomb Inc
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision...
Surgical Devices·2 affected·Nov 4, 2014
CriticalFDA
Bausch & Lomb Inc
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision En...
Surgical Devices·79 affected·Nov 4, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·5 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
RecallFDA
Coopersurgical, Inc.
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue f...
Surgical Devices·30 affected·Oct 27, 2014
High RiskFDA
Stryker Neurovascular
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial a...
Surgical Devices·1 affected·Oct 22, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Dr...
Surgical Devices·120 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral ...
Surgical Devices·90 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, in...
Surgical Devices·83 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introducti...
Surgical Devices·100 affected·Oct 20, 2014
High RiskFDA
Pfm Medical Inc
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chro...
Surgical Devices·85 affected·Oct 20, 2014
High RiskFDA
Biosense Webster, Inc.
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Surgical Devices·173,329 affected·Oct 19, 2014
High RiskFDA
Mallinckrodt Manufacturing Llc
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures...
Surgical Devices·246 affected·Oct 17, 2014
High RiskFDA
St Jude Medical
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Surgical Devices·26 affected·Oct 14, 2014
High RiskFDA
Medtronic Vascular
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Surgical Devices·11 affected·Oct 13, 2014
High RiskFDA
Zimmer, Inc.
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability d...
Surgical Devices·138 affected·Oct 9, 2014
CriticalFDA
Customed, Inc
Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound ...
Surgical Devices·2,670 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture re...
Surgical Devices·1,500 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wou...
Surgical Devices·2,640 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound he...
Surgical Devices·2,240 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, sutur...
Surgical Devices·354 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture re...
Surgical Devices·9,770 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irri...
Surgical Devices·880 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound heali...
Surgical Devices·4,710 affected·Oct 8, 2014