Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Hollister Incorporated
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a ...
Surgical Devices·1,031 affected·Feb 11, 2021
High RiskFDA
Mizuho Osi
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support...
Surgical Devices·26 affected·Feb 8, 2021
High RiskFDA
Alcon Research, Llc
Alcon Custom Ophthalmic Surgical Procedure Packs
Surgical Devices·249,853 affected·Feb 2, 2021
High RiskFDA
Bovie Medical Corporation
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during ...
Surgical Devices·5,270 affected·Feb 1, 2021
High RiskFDA
Epimed International, Inc.
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia an...
Surgical Devices·5,835 affected·Feb 1, 2021
High RiskFDA
Bovie Medical Corporation
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue durin...
Surgical Devices·5,894 affected·Feb 1, 2021
High RiskFDA
Olympus Corporation Of The Americas
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equip...
Surgical Devices·1,564 affected·Jan 28, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supportin...
Surgical Devices·37 affected·Jan 27, 2021
High RiskFDA
Deroyal Industries Inc
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom su...
Surgical Devices·309 affected·Jan 25, 2021
High RiskFDA
Steris Corporation
OT1000 Series Orthopedic Surgical Tables
Surgical Devices·272 affected·Jan 21, 2021
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36...
Surgical Devices·102 affected·Jan 19, 2021
High RiskFDA
Medtronic Vascular
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
Surgical Devices·137 affected·Jan 15, 2021
High RiskFDA
Medtronic Vascular
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Surgical Devices·10 affected·Jan 15, 2021
High RiskFDA
Northgate Technologies, Inc.
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumo...
Surgical Devices·25 affected·Jan 15, 2021
High RiskFDA
Medtronic Vascular
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Surgical Devices·9 affected·Jan 15, 2021
High RiskFDA
C.r. Bard, Inc.
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Surgical Devices·9,800 affected·Jan 11, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within th...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other me...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using hi...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Ethicon, Inc.
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgi...
Surgical Devices·23,580 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using hi...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within th...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within th...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medic...
Surgical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high...
Surgical Devices·7,400,000 affected·Jan 4, 2021
CriticalFDA
Getinge Group Logistics America, Llc
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying...
Surgical Devices·189 affected·Dec 21, 2020
CriticalFDA
Penumbra Inc.
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter wi...
Surgical Devices·27,499 affected·Dec 15, 2020
CriticalFDA
Penumbra Inc.
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) i...
Surgical Devices·3,368 affected·Dec 15, 2020
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shu...
Surgical Devices·85 affected·Dec 14, 2020
High RiskFDA
Prytime Medical Devices, Inc.
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, S...
Surgical Devices·0 affected·Dec 14, 2020
High RiskFDA
Integra Lifesciences Corp.
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospin...
Surgical Devices·17 affected·Dec 14, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·1,759 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·247 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curv...
Surgical Devices·863 affected·Dec 10, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a...
Surgical Devices·3,858 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component o...
Surgical Devices·3,165 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of...
Surgical Devices·1,926 affected·Dec 8, 2020
High RiskFDA
The Magstim Company Limited
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cran...
Surgical Devices·7 affected·Dec 8, 2020
High RiskFDA
Icu Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, steri...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single us...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, n...
Surgical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and ...
Surgical Devices·5,316 affected·Nov 23, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thora...
Surgical Devices·3,255 affected·Nov 23, 2020
High RiskFDA
Haag-streit Usa Inc
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes ...
Surgical Devices·3 affected·Nov 20, 2020