Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intend...
Surgical Devices·0 affected·Nov 25, 2015
High RiskFDA
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powere...
Surgical Devices·0 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Surgical Devices·1,035 affected·Nov 25, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are desig...
Surgical Devices·120 affected·Nov 23, 2015
High RiskFDA
Depuy Spine, Inc.
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Surgical Devices·16 affected·Nov 20, 2015
High RiskFDA
Steris Corporation
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irri...
Surgical Devices·2,319 affected·Nov 20, 2015
High RiskFDA
Cook Inc.
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles ...
Surgical Devices·35 affected·Nov 19, 2015
CriticalFDA
Stryker Sustainability Solutions
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, ac...
Surgical Devices·34 affected·Nov 17, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriat...
Surgical Devices·45 affected·Nov 13, 2015
High RiskFDA
Cardica, Inc.
MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip C...
Surgical Devices·568 affected·Nov 6, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserte...
Surgical Devices·1,445,180 affected·Nov 5, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - ...
Surgical Devices·136 affected·Nov 3, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - Th...
Surgical Devices·45 affected·Nov 3, 2015
High RiskFDA
Angiodynamics Inc.
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - ...
Surgical Devices·8 affected·Nov 3, 2015
High RiskFDA
Trumpf Medical Systems, Inc.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Surgical Devices·20,713 affected·Nov 2, 2015
High RiskFDA
The Anspach Effort, Inc.
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Surgical Devices·50 affected·Nov 2, 2015
High RiskFDA
Baylis Medical Corp *
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infus...
Surgical Devices·433 affected·Oct 28, 2015
High RiskFDA
Procedure Products, Inc.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further proces...
Surgical Devices·1,100 affected·Oct 27, 2015
High RiskFDA
Medtronic Vascular, Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210...
Surgical Devices·1,652 affected·Oct 23, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 1100...
Surgical Devices·1,139 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, ...
Surgical Devices·206 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with di...
Surgical Devices·54 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674...
Surgical Devices·508 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. ...
Surgical Devices·717 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and t...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Cook Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Surgical Devices·38 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Stryker Sustainability Solutions
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps a...
Surgical Devices·1,202 affected·Oct 14, 2015
High RiskFDA
Tz Medical Inc.
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverSt...
Surgical Devices·10,180 affected·Oct 14, 2015
CriticalFDA
Cook Inc.
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contras...
Surgical Devices·9,519 affected·Oct 7, 2015
CriticalFDA
Hummingbird Med
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial ...
Surgical Devices·11,500 affected·Oct 1, 2015
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Surgical Devices·23 affected·Sep 23, 2015
High RiskFDA
Materialise N.v.
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial ...
Surgical Devices·4 affected·Sep 23, 2015
High RiskFDA
Alcon Research, Ltd.
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical proc...
Surgical Devices·5 affected·Sep 21, 2015
High RiskFDA
Biocompatibles U.k., Ltd.
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery o...
Surgical Devices·64 affected·Sep 21, 2015
High RiskFDA
Encore Medical, Lp
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition...
Surgical Devices·20 affected·Sep 15, 2015
High RiskFDA
Intuitive Surgical, Inc.
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. ...
Surgical Devices·1,200 affected·Sep 9, 2015
RecallFDA
Coopersurgical, Inc.
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Surgical Devices·305 affected·Sep 1, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Surgical Devices·84 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
Surgical Devices·80 affected·Aug 25, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film...
Surgical Devices·8,970 affected·Aug 24, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Surgical Devices·67 affected·Aug 19, 2015