Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Surgical Devices·18 affected·Aug 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instr...
Surgical Devices·58 affected·Aug 3, 2023
High RiskFDA
Skytron, Llc
GS70H Salus Surgical Table, Product Code 18-071-70
Surgical Devices·24 affected·Aug 1, 2023
High RiskFDA
Edwards Lifesciences, Llc
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Surgical Devices·92 affected·Jul 27, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Surgical Devices·2 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical ...
Surgical Devices·1 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Surgical Devices·1 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Surgical Devices·3 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Surgical Devices·4 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Surgical Devices·0 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Surgical Devices·7 affected·Jul 13, 2023
High RiskFDA
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Surgical Devices·3 affected·Jul 13, 2023
High RiskFDA
Stryker Corporation
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and reco...
Surgical Devices·57 affected·Jul 10, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Surgical Devices·16 affected·Jul 3, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Surgical Devices·685 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Surgical Devices·6,949 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
Surgical Devices·3,965 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Surgical Devices·295 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
Surgical Devices·1,875 affected·Jun 28, 2023
High RiskFDA
Medtronic Neurosurgery
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Surgical Devices·44 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Surgical Devices·45,880 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Surgical Devices·7,293 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Surgical Devices·647 affected·Jun 28, 2023
High RiskFDA
Stryker Corporation
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, includin...
Surgical Devices·491 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
Surgical Devices·1,099 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
Surgical Devices·5,373 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
Surgical Devices·655 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Surgical Devices·775 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Surgical Devices·299 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
Surgical Devices·299 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
Surgical Devices·519 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Surgical Devices·600 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Surgical Devices·69,987 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Surgical Devices·6,615 affected·Jun 28, 2023
CriticalFDA
Datascope Corp.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descri...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product D...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Descrip...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Produc...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descripti...
Surgical Devices·321,609 affected·Jun 23, 2023
High RiskFDA
Materialise N.v.
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in ...
Surgical Devices·1 affected·Jun 19, 2023
CriticalFDA
Arrow International Inc.
ARROW Endurance Extended Dwell Peripheral Catheter System
Surgical Devices·262,016 affected·May 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) END...
Surgical Devices·4,644 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; ...
Surgical Devices·770,147 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI45...
Surgical Devices·620 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model ...
Surgical Devices·10,080 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A...
Surgical Devices·2,590 affected·May 18, 2023