Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·70 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·165 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·11 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·54 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·35 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·33 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·409 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·45 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·10 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·1 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·338 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·2 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·10 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·27 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·25 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·38 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·87 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·178 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·4 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·689 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·16 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·28 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·24 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
Ev3, Inc.
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Surgical Devices·27 affected·Mar 29, 2016
High RiskFDA
Hansen Medical Inc
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a roboti...
Surgical Devices·8 affected·Mar 25, 2016
CriticalFDA
Intuitive Surgical, Inc.
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intu...
Surgical Devices·43 affected·Mar 25, 2016
High RiskFDA
Hospira Inc.
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site an...
Surgical Devices·2,567 affected·Mar 25, 2016
CriticalFDA
Boston Scientific Corporation
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the ...
Surgical Devices·21,155 affected·Mar 22, 2016
High RiskFDA
Coloplast Manufacturing Us, Llc
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary cat...
Surgical Devices·31,320 affected·Mar 22, 2016
High RiskFDA
Stryker Neurovascular
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intend...
Surgical Devices·316 affected·Mar 21, 2016
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multip...
Surgical Devices·40 affected·Mar 21, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: T...
Surgical Devices·286 affected·Mar 21, 2016
High RiskFDA
Stryker Neurovascular
GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended...
Surgical Devices·316 affected·Mar 21, 2016
High RiskFDA
Windstone Medical Packaging, Inc.
General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple com...
Surgical Devices·170 affected·Mar 21, 2016
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Surgical Devices·0 affected·Mar 18, 2016
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Surgical Devices·63 affected·Mar 17, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UP...
Surgical Devices·2,716 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PA...
Surgical Devices·150 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid...
Surgical Devices·60 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC...
Surgical Devices·2 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid P...
Surgical Devices·10 affected·Mar 14, 2016
High RiskFDA
Integra York Pa, Inc
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Surgical Devices·678 affected·Mar 11, 2016
CriticalFDA
Integra Lifesciences Corp.
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Surgical Devices·2,487 affected·Mar 7, 2016
CriticalFDA
Integra Lifesciences Corp.
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Surgical Devices·30,146 affected·Mar 7, 2016
High RiskFDA
Alcon Research, Ltd.
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and gu...
Surgical Devices·97 affected·Mar 1, 2016