Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Surgical Devices·12,340 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Surgical Devices·1,562 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Surgical Devices·1,111 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Surgical Devices·373 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 471049
Surgical Devices·56,580 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Surgical Devices·2,852 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Surgical Devices·7,132 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Surgical Devices·1,739 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Surgical Devices·68,458 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of pro...
Surgical Devices·42,028 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a...
Surgical Devices·33,219 affected·Dec 19, 2024
CriticalFDA
Olympus Corporation Of The Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached...
Surgical Devices·30,140 affected·Dec 18, 2024
High RiskFDA
Ev3 Inc
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Si...
Surgical Devices·5,189 affected·Dec 10, 2024
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # W...
Surgical Devices·1,776 affected·Dec 4, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Surgical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO...
Surgical Devices·75 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Surgical Devices·150 affected·Dec 3, 2024
High RiskFDA
Coloplast Manufacturing Us, Llc
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, A...
Surgical Devices·36,369 affected·Dec 2, 2024
High RiskFDA
Microvention Inc.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Surgical Devices·107 affected·Dec 2, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Typ...
Surgical Devices·128,608 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·112 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Ty...
Surgical Devices·495,865 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·4,055 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·84,570 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·36,712 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·9,200 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model N...
Surgical Devices·34,325 affected·Nov 25, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assi...
Surgical Devices·84 affected·Nov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and...
Surgical Devices·100 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder n...
Surgical Devices·749 affected·Nov 18, 2024
CriticalFDA
Kirwan Surgical Products, Llc
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar ...
Surgical Devices·2,999 affected·Nov 14, 2024
CriticalFDA
Kirwan Surgical Products, Llc
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar P...
Surgical Devices·3,010 affected·Nov 14, 2024
CriticalFDA
Kirwan Surgical Products, Llc
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsu...
Surgical Devices·66 affected·Nov 14, 2024
CriticalFDA
Kirwan Surgical Products, Llc
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are design...
Surgical Devices·4,470 affected·Nov 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Surgical Devices·21,440 affected·Nov 12, 2024
High RiskFDA
O&m Halyard, Inc.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Surgical Devices·211 affected·Nov 8, 2024
High RiskFDA
Abbott Vascular Inc
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilat...
Surgical Devices·1,418 affected·Nov 6, 2024
High RiskFDA
Carwild Corporation
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Surgical Devices·300 affected·Oct 22, 2024
High RiskFDA
Carwild Corporation
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q6...
Surgical Devices·120 affected·Oct 22, 2024
High RiskFDA
Carwild Corporation
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Proce...
Surgical Devices·140 affected·Oct 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DY...
Surgical Devices·0 affected·Oct 16, 2024
High RiskFDA
Corneat Vision, Ltd.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Surgical Devices·0 affected·Oct 16, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Surgical Devices·20,290 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Surgical Devices·960 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Surgical Devices·368 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Surgical Devices·2,751 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Surgical Devices·5,913 affected·Oct 10, 2024
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including...
Surgical Devices·1,120,860 affected·Oct 4, 2024