Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Skeletal Kinetics, Llc
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill...
Surgical Devices·29 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids o...
Surgical Devices·116 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·263 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk...
Surgical Devices·48 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the ...
Surgical Devices·307 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or ...
Surgical Devices·35 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·491 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or ga...
Surgical Devices·32 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of ...
Surgical Devices·125 affected·Apr 6, 2020
High RiskFDA
Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler ind...
Surgical Devices·125 affected·Apr 3, 2020
RecallFDA
Pega Medical Inc.
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the gri...
Surgical Devices·3 affected·Apr 3, 2020
RecallFDA
Immersivetouch Inc
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating s...
Surgical Devices·2 affected·Apr 3, 2020
High RiskFDA
Boston Scientific Corporation
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, abla...
Surgical Devices·146,633 affected·Mar 30, 2020
High RiskFDA
Edwards Lifesciences, Llc
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Surgical Devices·597 affected·Mar 27, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model ...
Surgical Devices·85,586 affected·Mar 26, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pen...
Surgical Devices·40 affected·Mar 26, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model ...
Surgical Devices·4,348 affected·Mar 26, 2020
High RiskFDA
Becton Dickinson & Company
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403...
Surgical Devices·900 affected·Mar 26, 2020
High RiskFDA
Gentell, Inc
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11...
Surgical Devices·4,419 affected·Mar 26, 2020
CriticalFDA
Lemaitre Vascular, Inc.
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embol...
Surgical Devices·43,315 affected·Mar 23, 2020
High RiskFDA
Janus Trade Group
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-...
Surgical Devices·1,365 affected·Mar 23, 2020
High RiskFDA
Inari Medical
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Surgical Devices·318 affected·Mar 23, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,500 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·1,929 affected·Mar 17, 2020
High RiskFDA
Becton Dickinson & Company
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Surgical Devices·655 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·700 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·34,785 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·16,393 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·9,137 affected·Mar 17, 2020
High RiskFDA
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a senso...
Surgical Devices·2,698 affected·Mar 17, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Surgical Devices·30,877 affected·Mar 16, 2020
High RiskFDA
Aesthetics Biomedical, Inc.
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedure...
Surgical Devices·623 affected·Mar 13, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally en...
Surgical Devices·209 affected·Mar 5, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in micr...
Surgical Devices·0 affected·Mar 5, 2020
High RiskFDA
Acutus Medical Inc
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Surgical Devices·108 affected·Feb 25, 2020
CriticalFDA
Boston Scientific Corporation
Imager II 5F Angiographic Catheters, 5 units per package.
Surgical Devices·1,068,827 affected·Feb 11, 2020
High RiskFDA
Covidien Llc
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distri...
Surgical Devices·0 affected·Feb 10, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Surgical Devices·1 affected·Feb 3, 2020
High RiskFDA
Materialise N.v.
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Surgical Devices·1 affected·Feb 3, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
High RiskFDA
Cardinal Health 200, Llc
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January...
Surgical Devices·2,161,526 affected·Jan 31, 2020
High RiskFDA
Applied Medical Resources Corp
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clampi...
Surgical Devices·2,240 affected·Jan 31, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Ca...
Surgical Devices·791 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Cat...
Surgical Devices·791 affected·Jan 29, 2020
CriticalFDA
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Ca...
Surgical Devices·791 affected·Jan 29, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices·200 affected·Jan 28, 2020