Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014...
Surgical Devices·71,260 affected·Dec 6, 2021
CriticalFDA
Ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014"...
Surgical Devices·28,094 affected·Dec 6, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Surgical Devices·6,280 affected·Nov 22, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Surgical Devices·2,520 affected·Nov 22, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Surgical Devices·20 affected·Nov 22, 2021
High RiskFDA
Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Surgical Devices·270,839 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Surgical Devices·364,481 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Surgical Devices·363,480 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Surgical Devices·231,219 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Surgical Devices·17,174 affected·Nov 2, 2021
High RiskFDA
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Surgical Devices·169,262 affected·Nov 2, 2021
CriticalFDA
Cook Inc.
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal ...
Surgical Devices·4,789 affected·Oct 8, 2021
High RiskFDA
Beaver Visitec International, Inc.
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#3738...
Surgical Devices·125 affected·Oct 8, 2021
High RiskFDA
Beaver Visitec International, Inc.
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sam...
Surgical Devices·2 affected·Oct 8, 2021
High RiskFDA
Coopersurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Surgical Devices·193 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Surgical Devices·75 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Surgical Devices·154 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Surgical Devices·75 affected·Sep 29, 2021
High RiskFDA
Coopersurgical, Inc.
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
Surgical Devices·1,587 affected·Sep 29, 2021
High RiskFDA
Medtronic Perfusion Systems
Cardioblate CryoFlex Surgical Ablation Console
Surgical Devices·7 affected·Sep 27, 2021
CriticalFDA
Medtech Sas
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guide...
Surgical Devices·119 affected·Sep 22, 2021
High RiskFDA
Intuitive Surgical, Inc.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Ca...
Surgical Devices·1,740 affected·Sep 21, 2021
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous ...
Surgical Devices·1,167 affected·Sep 20, 2021
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous...
Surgical Devices·1,918 affected·Sep 20, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
C315-HIS Delivery Catheter
Surgical Devices·591 affected·Sep 9, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·15 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·0 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·846 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·138 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, ST...
Surgical Devices·187 affected·Sep 2, 2021
High RiskFDA
Deerfield Imaging, Inc.
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to su...
Surgical Devices·10 affected·Aug 25, 2021
High RiskFDA
Deerfield Imaging, Inc.
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to su...
Surgical Devices·13 affected·Aug 25, 2021
CriticalFDA
Imperative Care Inc
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx O...
Surgical Devices·3,118 affected·Aug 13, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·5 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·6 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·5 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), S...
Surgical Devices·333 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·58 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·3 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·98 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumen...
Surgical Devices·6,395 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous in...
Surgical Devices·1,253 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion cap...
Surgical Devices·2,833 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HE...
Surgical Devices·1,256 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens...
Surgical Devices·1,733 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capab...
Surgical Devices·5,524 affected·Aug 6, 2021