Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Surgical Devices·1,566 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Surgical Devices·1,231 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
Surgical Devices·748 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
Surgical Devices·1,447 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Surgical Devices·651 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
Surgical Devices·531 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
Surgical Devices·1,337 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Surgical Devices·1,142 affected·Nov 19, 2020
High RiskFDA
Shimadzu Medical Systems
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluo...
Surgical Devices·7 affected·Nov 18, 2020
High RiskFDA
Galt Medical Corporation
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Surgical Devices·9,920 affected·Nov 16, 2020
High RiskFDA
Integra Lifesciences Corp.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures....
Surgical Devices·552 affected·Nov 11, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The...
Surgical Devices·90 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/a...
Surgical Devices·42 affected·Nov 10, 2020
High RiskFDA
Boston Scientific Corporation
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter...
Surgical Devices·90 affected·Nov 3, 2020
High RiskFDA
Ga Health Company Limited
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ...
Surgical Devices·11,000 affected·Nov 3, 2020
High RiskFDA
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter with...
Surgical Devices·454 affected·Oct 23, 2020
CriticalFDA
Cook Inc.
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless st...
Surgical Devices·61 affected·Oct 22, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe t...
Surgical Devices·15 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe...
Surgical Devices·3 affected·Oct 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, dispos...
Surgical Devices·37 affected·Oct 12, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percuta...
Surgical Devices·281 affected·Oct 1, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical ...
Surgical Devices·62 affected·Sep 24, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventi...
Surgical Devices·6 affected·Sep 24, 2020
High RiskFDA
Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are int...
Surgical Devices·12,020 affected·Sep 14, 2020
High RiskFDA
Braxton Medical Corporation
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to ...
Surgical Devices·1,781 affected·Sep 4, 2020
High RiskFDA
Medline Industries Inc
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal...
Surgical Devices·6,225 affected·Sep 1, 2020
High RiskFDA
Encore Medical, Lp
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shou...
Surgical Devices·15 affected·Aug 31, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Us...
Surgical Devices·5,813 affected·Aug 31, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter.
Surgical Devices·89,121 affected·Aug 31, 2020
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheter
Surgical Devices·1,680 affected·Aug 31, 2020
High RiskFDA
Ev3 Inc.
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Surgical Devices·4,286 affected·Aug 26, 2020
High RiskFDA
Genicon, Inc.
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures ...
Surgical Devices·10,808 affected·Aug 25, 2020
High RiskFDA
Alcon Research, Llc
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by opht...
Surgical Devices·16,971 affected·Aug 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Surgical Devices·111 affected·Aug 3, 2020
High RiskFDA
Cme America, Llc
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at prec...
Surgical Devices·4,182 affected·Jul 30, 2020
High RiskFDA
Cme America, Llc
CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at...
Surgical Devices·4,182 affected·Jul 30, 2020
High RiskFDA
Cme America, Llc
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at ...
Surgical Devices·4,182 affected·Jul 30, 2020
High RiskFDA
Cme America, Llc
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermi...
Surgical Devices·4,182 affected·Jul 30, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Cardinal Health 200, Llc
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex o...
Surgical Devices·7,119,625 affected·Jul 29, 2020
High RiskFDA
Medical Components, Inc Dba Medcomp
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Surgical Devices·132 affected·Jul 27, 2020
High RiskFDA
Icu Medical, Inc.
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per...
Surgical Devices·1 affected·Jul 6, 2020