Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Arrow International Inc
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 ...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization ...
Surgical Devices·27 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization ...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The mu...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter pe...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Arrow International Inc
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous A...
Surgical Devices·27,485 affected·May 9, 2017
High RiskFDA
Sterilmed Inc
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate num...
Surgical Devices·963 affected·May 8, 2017
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instr...
Surgical Devices·16 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabil...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of ins...
Surgical Devices·1 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stab...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Kci Usa, Inc.
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Nega...
Surgical Devices·5,385 affected·Apr 28, 2017
High RiskFDA
Bard Access Systems Inc.
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film ...
Surgical Devices·4,500 affected·Apr 25, 2017
High RiskFDA
Molnlycke Health Care, Inc
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Surgical Devices·956 affected·Apr 24, 2017
High RiskFDA
Greatbatch Medical
Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Hand...
Surgical Devices·205 affected·Apr 23, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ste...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile ...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are s...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile sin...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile sing...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ste...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage System...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile singl...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Teleflex Medical
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Surgical Devices·19,043 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wo...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are ...
Surgical Devices·0 affected·Apr 21, 2017
High RiskFDA
Conmed Corporation
Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthr...
Surgical Devices·56 affected·Apr 17, 2017
High RiskFDA
Vascular Solutions, Inc.
Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device u...
Surgical Devices·4,110 affected·Apr 12, 2017
High RiskFDA
Biomet Microfixation, Llc
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Surgical Devices·33 affected·Apr 11, 2017
High RiskFDA
Boston Scientific Corporation
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral v...
Surgical Devices·137 affected·Apr 5, 2017
High RiskFDA
Mederi Therapeutics, Inc
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesopha...
Surgical Devices·1,458 affected·Apr 3, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440...
Surgical Devices·15 affected·Mar 31, 2017
High RiskFDA
Teleflex Medical
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lac...
Surgical Devices·3,594 affected·Mar 24, 2017
CriticalFDA
Abbott Vascular
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 101...
Surgical Devices·449,661 affected·Mar 22, 2017
CriticalFDA
Abbott Vascular
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20...
Surgical Devices·449,661 affected·Mar 22, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard An...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circ...
Surgical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits ven...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and C...
Surgical Devices·43,394 affected·Mar 20, 2017