Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Encore Medical, Lp
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Surgical Devices·10 affected·May 12, 2021
High RiskFDA
Encore Medical, Lp
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Surgical Devices·10 affected·May 12, 2021
CriticalFDA
Nico Corp.
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-70...
Surgical Devices·80 affected·Apr 30, 2021
High RiskFDA
Coopersurgical, Inc.
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electr...
Surgical Devices·20 affected·Apr 30, 2021
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the perip...
Surgical Devices·690 affected·Apr 26, 2021
High RiskFDA
Adler Micromed, Inc.
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. D...
Surgical Devices·1,858 affected·Apr 23, 2021
RecallFDA
Microvention Inc.
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewi...
Surgical Devices·0 affected·Apr 21, 2021
RecallFDA
Microvention Inc.
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewi...
Surgical Devices·0 affected·Apr 21, 2021
High RiskFDA
Anodyne Surgical
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, R...
Surgical Devices·8,452 affected·Apr 21, 2021
High RiskFDA
Spes Medica
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached...
Surgical Devices·34 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuo...
Surgical Devices·20 affected·Apr 8, 2021
High RiskFDA
Windstone Medical Packaging, Inc.
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS...
Surgical Devices·114 affected·Apr 8, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is desig...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UD...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, ...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is d...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Cardiac Assist, Inc
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 ...
Surgical Devices·13 affected·Mar 19, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product U...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usag...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock;...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Dro...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the adm...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the adm...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product U...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Boston Scientific Corporation
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in ...
Surgical Devices·52 affected·Mar 5, 2021
High RiskFDA
Covidien
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083...
Surgical Devices·59,828 affected·Mar 5, 2021
High RiskFDA
Access Vascular, Inc.
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Surgical Devices·79 affected·Feb 24, 2021
High RiskFDA
Trinity Sterile, Inc.
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dres...
Surgical Devices·2,970 affected·Feb 23, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction o...
Surgical Devices·337 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·18 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:...
Surgical Devices·19 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:D...
Surgical Devices·13 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·15 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CE...
Surgical Devices·100 affected·Feb 22, 2021