Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. for cardiovascular use
Surgical Devices·3,058 affected·Mar 15, 2019
High RiskFDA
Medical Components, Inc Dba Medcomp
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Surgical Devices·6,830 affected·Mar 13, 2019
High RiskFDA
Medical Components, Inc Dba Medcomp
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing ...
Surgical Devices·6,830 affected·Mar 13, 2019
RecallFDA
Teleflex Medical
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Surgical Devices·39,456 affected·Feb 27, 2019
RecallFDA
Beaver Visitec
Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and...
Surgical Devices·97 affected·Feb 19, 2019
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-800...
Surgical Devices·9 affected·Feb 8, 2019
RecallFDA
Cordis Corporation
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduc...
Surgical Devices·23,481 affected·Feb 7, 2019
High RiskFDA
Medrobotics Corporation
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to ...
Surgical Devices·35 affected·Jan 25, 2019
High RiskFDA
Arrow International Inc
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Surgical Devices·45 affected·Jan 10, 2019
High RiskFDA
Convatec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary ...
Surgical Devices·5,744,525 affected·Jan 9, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to sup...
Surgical Devices·6 affected·Jan 8, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is de...
Surgical Devices·6 affected·Jan 8, 2019
CriticalFDA
Getinge Us Sales Llc
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product ...
Surgical Devices·6 affected·Jan 8, 2019
High RiskFDA
Cook Inc.
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
Surgical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Surgical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Surgical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Surgical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Wilson-cook Medical Inc.
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Surgical Devices·34,456 affected·Jan 4, 2019
High RiskFDA
Leica Microsystems, Inc.
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of ob...
Surgical Devices·15 affected·Jan 2, 2019
High RiskFDA
Fetzer Medical Gmbh & Co. Kg
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps...
Surgical Devices·2 affected·Dec 28, 2018
High RiskFDA
Cook Inc.
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Su...
Surgical Devices·975 affected·Dec 19, 2018
High RiskFDA
Cook Inc.
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Su...
Surgical Devices·797 affected·Dec 19, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy an...
Surgical Devices·1,404 affected·Dec 18, 2018
High RiskFDA
Wilson-cook Medical Inc.
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Surgical Devices·8 affected·Dec 18, 2018
High RiskFDA
Wilson-cook Medical Inc.
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
Surgical Devices·6 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Surgical Devices·180 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy a...
Surgical Devices·504 affected·Dec 18, 2018
High RiskFDA
Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydr...
Surgical Devices·4,800 affected·Dec 14, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·65 affected·Dec 10, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·46 affected·Dec 10, 2018
High RiskFDA
Spectranetics Corporation
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. ...
Surgical Devices·3 affected·Dec 7, 2018
CriticalFDA
Ethicon Endo-surgery Inc
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessori...
Surgical Devices·15,264 affected·Dec 7, 2018
High RiskFDA
Carl Zeiss Meditec, Inc.
VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Las...
Surgical Devices·66 affected·Dec 6, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System ...
Surgical Devices·157 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used ...
Surgical Devices·45 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is i...
Surgical Devices·68 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation Sys...
Surgical Devices·4 affected·Dec 3, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System
Surgical Devices·74 affected·Nov 21, 2018
High RiskFDA
Stryker Communications
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0...
Surgical Devices·3,176 affected·Nov 13, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 a...
Surgical Devices·15 affected·Nov 6, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are i...
Surgical Devices·14 affected·Nov 6, 2018
High RiskFDA
Covidien Llc
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Surgical Devices·32,071 affected·Nov 5, 2018
High RiskFDA
Cardinal Health 200, Llc
Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made o...
Surgical Devices·1,475,095 affected·Oct 31, 2018
High RiskFDA
Cardinal Health 200, Llc
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made o...
Surgical Devices·1,475,095 affected·Oct 31, 2018
High RiskFDA
Cardinal Health 200, Llc
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made o...
Surgical Devices·1,475,095 affected·Oct 31, 2018
High RiskFDA
Cardinal Health 200, Llc
Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposab...
Surgical Devices·1,475,095 affected·Oct 31, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope pack...
Surgical Devices·0 affected·Oct 17, 2018