Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound tra...
Surgical Devices·177 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for ...
Surgical Devices·0 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for u...
Surgical Devices·712 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for u...
Surgical Devices·55 affected·Feb 23, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures t...
Surgical Devices·17 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for ...
Surgical Devices·385 affected·Feb 23, 2018
High RiskFDA
Medical Components, Inc Dba Medcomp
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged f...
Surgical Devices·315 affected·Feb 23, 2018
High RiskFDA
Allen Medical Systems
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table...
Surgical Devices·83 affected·Feb 21, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chl...
Surgical Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Ra Medical Systems Inc
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in t...
Surgical Devices·4 affected·Feb 15, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Surgical Devices·876 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Surgical Devices·3,196 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Surgical Devices·383 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Surgical Devices·2,835 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Surgical Devices·359 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Surgical Devices·2,395 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Surgical Devices·181 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Surgical Devices·1,411 affected·Feb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Surgical Devices·1,551 affected·Feb 8, 2018
High RiskFDA
Getinge Us Sales Llc
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ...
Surgical Devices·5,214 affected·Feb 7, 2018
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, It...
Surgical Devices·11,500 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, St...
Surgical Devices·7,600 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The...
Surgical Devices·100 affected·Feb 5, 2018
High RiskFDA
3m Company - Health Care Business
3M Surgical Clipper Professional 9681
Surgical Devices·120,000 affected·Feb 2, 2018
High RiskFDA
Medline Industries Inc
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Surgical Devices·90,870 affected·Feb 1, 2018
High RiskFDA
Orthofix Srl
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX ...
Surgical Devices·408 affected·Jan 30, 2018
High RiskFDA
Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Sy...
Surgical Devices·850 affected·Jan 26, 2018
High RiskFDA
Ellex Iscience, Inc.
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScien...
Surgical Devices·90 affected·Jan 11, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Surgical Devices·2,914 affected·Jan 3, 2018
High RiskFDA
Bard Access Systems Inc.
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag conf...
Surgical Devices·53,699 affected·Dec 28, 2017
High RiskFDA
Mako Surgical Corporation
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA),...
Surgical Devices·736 affected·Dec 27, 2017
High RiskFDA
Arrow International Inc
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue Fl...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-4570...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-251...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) ...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, P...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Surgical Devices·5,026 affected·Dec 20, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine...
Surgical Devices·226 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Cathet...
Surgical Devices·473 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vit...
Surgical Devices·21 affected·Dec 19, 2017
High RiskFDA
Trumpf Medical Systems, Inc.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpos...
Surgical Devices·212 affected·Dec 15, 2017
High RiskFDA
C.r. Bard, Inc.
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Surgical Devices·0 affected·Dec 13, 2017
High RiskFDA
Boston Scientific Corporation
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establ...
Surgical Devices·3,762 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is...
Surgical Devices·2,614 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended ...
Surgical Devices·1,480 affected·Dec 12, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit th...
Surgical Devices·31,005 affected·Dec 11, 2017
High RiskFDA
Stryker Neurovascular
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Surgical Devices·0 affected·Nov 28, 2017