Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Cook Inc.
Left Atrial Catheter Set
Surgical Devices·56 affected·Oct 13, 2017
High RiskFDA
Cook Inc.
Central Venous Catheter Tray
Surgical Devices·13 affected·Oct 13, 2017
High RiskFDA
Medline Industries Inc
MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
Surgical Devices·120 affected·Oct 10, 2017
High RiskFDA
Allen Medical Systems
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Surgical Devices·161 affected·Oct 6, 2017
High RiskFDA
Allen Medical Systems
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Surgical Devices·161 affected·Oct 6, 2017
CriticalFDA
Monteris Medical Corp
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Surgical Devices·52 affected·Oct 5, 2017
High RiskFDA
The Anspach Effort, Inc.
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to c...
Surgical Devices·1 affected·Sep 29, 2017
High RiskFDA
Integra Lifesciences Corp.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a co...
Surgical Devices·155 affected·Sep 26, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Surgical Devices·51 affected·Sep 25, 2017
High RiskFDA
Boston Scientific Corporation
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Surgical Devices·9 affected·Sep 22, 2017
High RiskFDA
Angiodynamics, Inc.
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angi...
Surgical Devices·28 affected·Sep 22, 2017
High RiskFDA
Boston Scientific Corporation
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Surgical Devices·2 affected·Sep 22, 2017
High RiskFDA
Covidien Llc
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and ba...
Surgical Devices·17,271 affected·Sep 21, 2017
High RiskFDA
C.r. Bard, Inc.
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 P...
Surgical Devices·44,640 affected·Sep 14, 2017
High RiskFDA
C.r. Bard, Inc.
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbe...
Surgical Devices·10,949,013 affected·Sep 14, 2017
High RiskFDA
Terumo Medical Corporation
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to b...
Surgical Devices·33 affected·Sep 12, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Surgical Devices·329 affected·Sep 6, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, ...
Surgical Devices·2,012 affected·Aug 31, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient...
Surgical Devices·2,012 affected·Aug 31, 2017
High RiskFDA
Icu Medical, Inc.
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B...
Surgical Devices·24,475 affected·Aug 31, 2017
High RiskFDA
Orthoscan, Inc.
Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, ...
Surgical Devices·2,012 affected·Aug 31, 2017
CriticalFDA
Spectranetics Corporation
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon ...
Surgical Devices·2,356 affected·Aug 7, 2017
High RiskFDA
Cook Inc.
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous cathet...
Surgical Devices·50 affected·Jul 31, 2017
High RiskFDA
Cook Inc.
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH P...
Surgical Devices·75 affected·Jul 31, 2017
High RiskFDA
C.r. Bard, Inc.
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in pat...
Surgical Devices·45,270 affected·Jul 28, 2017
High RiskFDA
Arrow International Inc
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Surgical Devices·2,691 affected·Jul 25, 2017
High RiskFDA
Epimed International
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, Fo...
Surgical Devices·500 affected·Jul 24, 2017
High RiskFDA
Teleflex Medical
Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate so...
Surgical Devices·20,039 affected·Jul 19, 2017
High RiskFDA
Teleflex Medical
Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft ...
Surgical Devices·20,039 affected·Jul 19, 2017
High RiskFDA
Teleflex Medical
Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to acce...
Surgical Devices·20,039 affected·Jul 19, 2017
CriticalFDA
Microline Surgical, Inc.
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, g...
Surgical Devices·61,769 affected·Jul 13, 2017
High RiskFDA
Medtronic Vascular Galway Dba Medtronic Ireland
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Surgical Devices·105,633 affected·Jul 13, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to o...
Surgical Devices·0 affected·Jul 10, 2017
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to ef...
Surgical Devices·200 affected·Jul 6, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Surgical Devices·6 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL C02 Laser surgical lasers
Surgical Devices·92 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Diode Laser surgical lasers
Surgical Devices·13 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL Station surgical lasers
Surgical Devices·199 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Surgical Devices·11 affected·Jul 3, 2017
High RiskFDA
Carefusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock ...
Surgical Devices·1,546,800 affected·Jun 30, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Str...
Surgical Devices·6 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70...
Surgical Devices·13 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The ...
Surgical Devices·60 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. Th...
Surgical Devices·75 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name ...
Surgical Devices·8 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450,...
Surgical Devices·15 affected·Jun 29, 2017
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
Surgical Devices·15 affected·Jun 27, 2017
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
Surgical Devices·470 affected·Jun 27, 2017