Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of s...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgi...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a va...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of sur...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover...
Surgical Devices·442,475 affected·Mar 16, 2015
High RiskFDA
Microtek Medical Inc
VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are i...
Surgical Devices·30,796 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to ev...
Surgical Devices·9,168 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended...
Surgical Devices·3,180 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX ...
Surgical Devices·10 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be wor...
Surgical Devices·11 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be wo...
Surgical Devices·153 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX I...
Surgical Devices·303 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgic...
Surgical Devices·38 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accesso...
Surgical Devices·5,889 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intende...
Surgical Devices·32,496 affected·Mar 10, 2015
High RiskFDA
Microtek Medical Inc
LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: ...
Surgical Devices·270 affected·Mar 10, 2015
High RiskFDA
Spinefrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgi...
Surgical Devices·5 affected·Mar 5, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgic...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Inst...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleedi...
Surgical Devices·274 affected·Feb 26, 2015
High RiskFDA
Ethicon Endo-surgery Inc
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open...
Surgical Devices·6,744 affected·Feb 26, 2015
High RiskFDA
Boston Scientific Corporation
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Surgical Devices·289 affected·Feb 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage ...
Surgical Devices·918 affected·Feb 25, 2015
RecallFDA
Lemaitre Vascular, Inc.
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incom...
Surgical Devices·54 affected·Feb 24, 2015
High RiskFDA
Titan Spine, Llc
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instr...
Surgical Devices·26 affected·Feb 20, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Bos...
Surgical Devices·1 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number...
Surgical Devices·4 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repack...
Surgical Devices·1 affected·Feb 11, 2015
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sea...
Surgical Devices·3,282 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP ...
Surgical Devices·2 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Cat...
Surgical Devices·6 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager),...
Surgical Devices·1 affected·Feb 11, 2015
High RiskFDA
Exp Pharmaceutical Services Corp
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF1...
Surgical Devices·1 affected·Feb 11, 2015
High RiskFDA
Derma Pen, Llc
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is p...
Surgical Devices·1,466 affected·Feb 5, 2015
High RiskFDA
Zipline Medical
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incisio...
Surgical Devices·3,109 affected·Feb 5, 2015
High RiskFDA
Materialise N.v.
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the ...
Surgical Devices·1 affected·Feb 4, 2015
CriticalFDA
Coopersurgical, Inc.
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase ...
Surgical Devices·20,398,889 affected·Jan 26, 2015
High RiskFDA
Intuitive Surgical, Inc.
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. In...
Surgical Devices·12,467 affected·Jan 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intui...
Surgical Devices·1,034 affected·Jan 15, 2015
RecallFDA
Arrow International Inc
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Surgical Devices·4,484 affected·Jan 9, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Acce...
Surgical Devices·399 affected·Jan 7, 2015
High RiskFDA
Arrow International Inc
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a condui...
Surgical Devices·63,022 affected·Jan 5, 2015
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation ...
Surgical Devices·1,195 affected·Jan 2, 2015
High RiskFDA
Clinical Innovations, Llc
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Surgical Devices·827 affected·Dec 30, 2014
High RiskFDA
Synthes, Inc.
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutti...
Surgical Devices·249 affected·Dec 19, 2014
High RiskFDA
Ziemer Usa Inc
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Surgical Devices·26 affected·Dec 18, 2014