Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Customed, Inc
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·162,000 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Surgical Devices·10 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem...
Surgical Devices·320 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture...
Surgical Devices·1,248 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Surgical Devices·413 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutu...
Surgical Devices·138 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem...
Surgical Devices·320 affected·Jul 10, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Surgical Devices·91,140 affected·Jul 7, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent ca...
Surgical Devices·534,972 affected·Jul 7, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Surgical Devices·37,686 affected·Jul 7, 2015
CriticalFDA
Cook Inc.
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the deli...
Surgical Devices·268,169 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast ...
Surgical Devices·248,167 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of c...
Surgical Devices·451,550 affected·Jul 2, 2015
High RiskFDA
Myoscience Inc
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually pac...
Surgical Devices·12 affected·Jul 1, 2015
High RiskFDA
Merit Medical Systems, Inc.
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Surgical Devices·950 affected·Jun 29, 2015
High RiskFDA
Ekos Corporation
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular ...
Surgical Devices·46 affected·Jun 24, 2015
High RiskFDA
Coopersurgical, Inc.
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilator...
Surgical Devices·40 affected·Jun 19, 2015
High RiskFDA
Atrium Medical Corporation
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Surgical Devices·62 affected·Jun 19, 2015
High RiskFDA
Symmetry Surgical, Inc.
SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws for...
Surgical Devices·2,708 affected·Jun 16, 2015
High RiskFDA
Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective mark...
Surgical Devices·524 affected·Jun 10, 2015
High RiskFDA
Stryker Sustainability Solutions
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopi...
Surgical Devices·147,351 affected·Jun 1, 2015
High RiskFDA
Stryker Sustainability Solutions
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro end...
Surgical Devices·147,351 affected·Jun 1, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for di...
Surgical Devices·3 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for...
Surgical Devices·4 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for di...
Surgical Devices·7 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for dia...
Surgical Devices·1 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for di...
Surgical Devices·10 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for dia...
Surgical Devices·13 affected·May 29, 2015
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of t...
Surgical Devices·646 affected·May 29, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for di...
Surgical Devices·17 affected·May 29, 2015
High RiskFDA
Barco Inc.
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
Surgical Devices·462 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but no...
Surgical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including,...
Surgical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but no...
Surgical Devices·16 affected·May 28, 2015
High RiskFDA
Cook Inc.
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular...
Surgical Devices·661 affected·May 28, 2015
RecallFDA
Bard Access Systems
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC S...
Surgical Devices·0 affected·May 27, 2015
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orth...
Surgical Devices·117 affected·May 27, 2015
RecallFDA
Bard Access Systems
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are ...
Surgical Devices·0 affected·May 27, 2015
RecallFDA
Bard Access Systems
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are int...
Surgical Devices·0 affected·May 27, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000,...
Surgical Devices·9,245 affected·May 22, 2015
High RiskFDA
Baxter Healthcare Corp
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Surgical Devices·23,600 affected·May 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tis...
Surgical Devices·2,436 affected·May 21, 2015
High RiskFDA
Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker ...
Surgical Devices·32,400 affected·May 20, 2015
High RiskFDA
Cook Inc.
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior ...
Surgical Devices·123,184 affected·May 14, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. ...
Surgical Devices·21 affected·May 12, 2015
High RiskFDA
Ethicon, Inc.
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cu...
Surgical Devices·1,922 affected·May 8, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Surgical Devices·214 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
Surgical Devices·621 affected·May 1, 2015