Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·7,024 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage:...
Surgical Devices·166 affected·Jul 3, 2018
High RiskFDA
Convatec, Inc
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile...
Surgical Devices·3,881 affected·Jul 3, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a...
Surgical Devices·95 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient d...
Surgical Devices·409 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to suppor...
Surgical Devices·1 affected·Jun 29, 2018
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgi...
Surgical Devices·385 affected·Jun 22, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-wa...
Surgical Devices·92,150 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,133 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·2,461 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·34,627 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way...
Surgical Devices·4,332 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·250 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use...
Surgical Devices·500 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·5,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·16,350 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·11,488 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Fol...
Surgical Devices·330 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·1,000 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley C...
Surgical Devices·1,588 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·14,326 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,025 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·1,028 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley ...
Surgical Devices·475 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·2,784 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone ...
Surgical Devices·153 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley...
Surgical Devices·4,372 affected·Jun 21, 2018
High RiskFDA
Degania Silicone, Ltd.
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone F...
Surgical Devices·250 affected·Jun 21, 2018
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Descript...
Surgical Devices·4,848 affected·Jun 19, 2018
High RiskFDA
Bovie Medical Corporation
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma ...
Surgical Devices·1,176 affected·Jun 18, 2018
High RiskFDA
Maquet Sas
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; A...
Surgical Devices·151 affected·Jun 14, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Surgical Devices·573 affected·Jun 12, 2018
High RiskFDA
Cryolife, Inc.
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achiev...
Surgical Devices·855 affected·Jun 4, 2018
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in en...
Surgical Devices·3,108 affected·Jun 4, 2018
CriticalFDA
Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Surgical Devices·1 affected·May 17, 2018
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous acces...
Surgical Devices·1,200 affected·May 11, 2018
High RiskFDA
Anika Therapeutics, Inc.
Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfo...
Surgical Devices·1,711 affected·May 10, 2018
High RiskFDA
Medtech Sas
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is in...
Surgical Devices·29 affected·May 8, 2018
High RiskFDA
Vascular Solutions, Inc.
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis c...
Surgical Devices·276 affected·May 4, 2018
High RiskFDA
Ethicon Endo-surgery Inc
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product...
Surgical Devices·146,326 affected·May 3, 2018
High RiskFDA
Galt Medical Corporation
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Cath...
Surgical Devices·13,210 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Surgical Devices·300 affected·May 2, 2018
High RiskFDA
Medline Industries Inc
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be us...
Surgical Devices·38,464 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Fo...
Surgical Devices·2,600 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product...
Surgical Devices·80,200 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product ...
Surgical Devices·23,150 affected·Apr 24, 2018