Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Customed, Inc
Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical staff to perform patient care procedures such as wound healin...
Surgical Devices·280 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture ...
Surgical Devices·185,000 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as w...
Surgical Devices·192 affected·Oct 8, 2014
High RiskFDA
Zimmer Surgical Inc
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam ...
Surgical Devices·828 affected·Oct 6, 2014
High RiskFDA
Alcon Research, Ltd.
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsu...
Surgical Devices·6,597 affected·Oct 6, 2014
High RiskFDA
Perouse Medical
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain...
Surgical Devices·24,821 affected·Oct 6, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and...
Surgical Devices·5 affected·Oct 3, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgi...
Surgical Devices·311 affected·Oct 3, 2014
RecallFDA
Coopersurgical, Inc.
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex si...
Surgical Devices·6 affected·Sep 30, 2014
RecallFDA
Coopersurgical, Inc.
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silic...
Surgical Devices·17 affected·Sep 30, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgica...
Surgical Devices·6,358 affected·Sep 29, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Post-op Surgical Kits Wound management
Surgical Devices·79,677 affected·Sep 26, 2014
High RiskFDA
Teleflex Medical
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handl...
Surgical Devices·6,197 affected·Sep 26, 2014
High RiskFDA
Sterilmed, Inc.
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Surgical Devices·22 affected·Sep 24, 2014
High RiskFDA
C P Medical, Inc.
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is s...
Surgical Devices·74 affected·Sep 22, 2014
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit
Surgical Devices·65 affected·Sep 18, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bip...
Surgical Devices·1,483 affected·Sep 17, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospi...
Surgical Devices·1,145 affected·Sep 15, 2014
High RiskFDA
Arrow International Inc
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Surgical Devices·300 affected·Sep 15, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Surgical Devices·61 affected·Sep 15, 2014
High RiskFDA
Codman & Shurtleff, Inc.
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cereb...
Surgical Devices·93,558 affected·Sep 15, 2014
High RiskFDA
Ge Oec Medical Systems, Inc
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Surgical Devices·61 affected·Sep 15, 2014
High RiskFDA
Instrumed International, Inc.
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·2 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries,...
Surgical Devices·81 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or di...
Surgical Devices·190 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on ...
Surgical Devices·5 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Sy...
Surgical Devices·26 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known forc...
Surgical Devices·3 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medl...
Surgical Devices·421 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping ...
Surgical Devices·26 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·4 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold u...
Surgical Devices·9 affected·Sep 8, 2014
RecallFDA
Coloplast Manufacturing Us, Llc
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is...
Surgical Devices·6 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Surgical Devices·790 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine i...
Surgical Devices·22 affected·Sep 8, 2014
High RiskFDA
Vygon Corporation
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, i...
Surgical Devices·42,250 affected·Aug 28, 2014
High RiskFDA
Justright Surgical, Llc
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one ...
Surgical Devices·3 affected·Aug 27, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to...
Surgical Devices·65 affected·Aug 27, 2014
High RiskFDA
Gyrus Medical, Inc
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw ...
Surgical Devices·5,520 affected·Aug 27, 2014
High RiskFDA
Justright Surgical, Llc
Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The J...
Surgical Devices·3 affected·Aug 27, 2014
High RiskFDA
Bard Peripheral Vascular Inc
Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW01...
Surgical Devices·177,760 affected·Aug 26, 2014
High RiskFDA
Volcano Corporation
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter stead...
Surgical Devices·8,251 affected·Aug 13, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microi...
Surgical Devices·134,554 affected·Aug 8, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Acc...
Surgical Devices·135,284 affected·Aug 8, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access ...
Surgical Devices·16,410 affected·Aug 8, 2014
High RiskFDA
Galt Medical Corporation
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to intr...
Surgical Devices·11,155 affected·Jul 25, 2014
High RiskFDA
Galt Medical Corporation
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in ...
Surgical Devices·11,155 affected·Jul 25, 2014
CriticalFDA
Cook Inc.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in...
Surgical Devices·696 affected·Jul 17, 2014