Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FB...
Surgical Devices·551,154 affected·May 6, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Surgical Devices·370 affected·May 2, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Surgical Devices·1,710 affected·May 2, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - Se...
Surgical Devices·198,205 affected·Apr 28, 2025
High RiskFDA
Virtual Incision Corporation
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Surgical Devices·3 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Numed Inc
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Surgical Devices·4 affected·Apr 21, 2025
CriticalFDA
Centerline Biomedical Inc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a cath...
Surgical Devices·80 affected·Apr 11, 2025
High RiskFDA
Tornier S.a.s.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Surgical Devices·438 affected·Apr 10, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Surgical Devices·6 affected·Apr 4, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PL...
Surgical Devices·189 affected·Apr 4, 2025
High RiskFDA
Klinika Mdical Gmb
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical devic...
Surgical Devices·160 affected·Apr 4, 2025
High RiskFDA
Galt Medical Corporation
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and oth...
Surgical Devices·100 affected·Mar 27, 2025
High RiskFDA
Galt Medical Corporation
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intend...
Surgical Devices·1,400 affected·Mar 27, 2025
High RiskFDA
Galt Medical Corporation
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer Syst...
Surgical Devices·100 affected·Mar 27, 2025
High RiskFDA
Ge Medical Systems, Llc
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional ...
Surgical Devices·3,472 affected·Mar 21, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description...
Surgical Devices·0 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Balla...
Surgical Devices·1,980 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Bal...
Surgical Devices·9,960 affected·Mar 19, 2025
High RiskFDA
Abbott
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Surgical Devices·2,683 affected·Mar 17, 2025
CriticalFDA
Conavi Medical Inc.
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Comm...
Surgical Devices·685 affected·Mar 12, 2025
High RiskFDA
Philips North America Llc
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and ...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional a...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,...
Surgical Devices·1,490 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introdu...
Surgical Devices·8,515 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Surgical Devices·1,118 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., ...
Surgical Devices·12 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., ...
Surgical Devices·1 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., ...
Surgical Devices·1,695 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Surgical Devices·220 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. ...
Surgical Devices·2,422 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Surgical Devices·643 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Surgical Devices·3 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF ...
Surgical Devices·2,236 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Surgical Devices·2,311 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Surgical Devices·506 affected·Feb 13, 2025
High RiskFDA
Cordis Us Corp
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introd...
Surgical Devices·12 affected·Feb 7, 2025
High RiskFDA
Aesculap Inc
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Fo...
Surgical Devices·47,078 affected·Jan 31, 2025
High RiskFDA
Aesculap Inc
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hys...
Surgical Devices·19,979 affected·Jan 31, 2025
High RiskFDA
Aesculap Inc
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL ...
Surgical Devices·917,965 affected·Jan 31, 2025
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Surgical Devices·50 affected·Dec 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Surgical Devices·1,200 affected·Dec 23, 2024
High RiskFDA
Ethicon, Llc
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxi...
Surgical Devices·15,948 affected·Dec 20, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Surgical Devices·99,249 affected·Dec 19, 2024