Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Arrow International Inc
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of cat...
Surgical Devices·121 affected·Oct 9, 2013
RecallFDA
Advanced Sterilization Products
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13...
Surgical Devices·267 affected·Oct 3, 2013
High RiskFDA
Ethicon Endo-surgery Inc
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use...
Surgical Devices·2,200 affected·Sep 30, 2013
High RiskFDA
Ethicon Endo-surgery Inc
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use...
Surgical Devices·2 affected·Sep 30, 2013
High RiskFDA
B. Braun Medical, Inc.
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety ...
Surgical Devices·55,200 affected·Sep 27, 2013
High RiskFDA
Concentric Medical Inc
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the...
Surgical Devices·87 affected·Sep 26, 2013
High RiskFDA
Medtronic Vascular, Inc.
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtroni...
Surgical Devices·122 affected·Sep 16, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Surgical Devices·200 affected·Sep 13, 2013
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid M...
Surgical Devices·368 affected·Aug 29, 2013
High RiskFDA
Spinefrontier, Inc.
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusi...
Surgical Devices·67 affected·Aug 28, 2013
High RiskFDA
Biomet Spine, Llc
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used...
Surgical Devices·14 affected·Aug 22, 2013
High RiskFDA
Zeppessis Reprocessing, Llc
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Wa...
Surgical Devices·0 affected·Aug 16, 2013
High RiskFDA
Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blo...
Surgical Devices·160 affected·Aug 16, 2013
High RiskFDA
Steris Corporation
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are u...
Surgical Devices·127 affected·Aug 15, 2013
CriticalFDA
Medline Industries, Inc.
CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·304 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·112 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·10 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·5 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·120 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com ...
Surgical Devices·10 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.med...
Surgical Devices·50 affected·Aug 14, 2013
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE...
Surgical Devices·726 affected·Aug 12, 2013
High RiskFDA
Megadyne Medical Products, Inc.
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. T...
Surgical Devices·1,816 affected·Aug 7, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are ind...
Surgical Devices·1,331 affected·Jul 31, 2013
High RiskFDA
Arrow International Inc
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central...
Surgical Devices·156 affected·Jul 31, 2013
High RiskFDA
Stryker Craniomaxillofacial Division
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 3970...
Surgical Devices·12,719 affected·Jul 30, 2013
High RiskFDA
Aso, Llc
Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 4091...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, c...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secur...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secur...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Gyrus Medical, Inc
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYO...
Surgical Devices·1,140 affected·Jul 24, 2013
High RiskFDA
Mckesson Technologies Inc
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and cont...
Surgical Devices·106 affected·Jul 22, 2013
High RiskFDA
Biomet 3i, Llc
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave pr...
Surgical Devices·170 affected·Jul 22, 2013
High RiskFDA
Biomet 3i, Llc
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Surgical Devices·21 affected·Jul 22, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access ...
Surgical Devices·4,285 affected·Jul 17, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Surgical Devices·170 affected·Jul 17, 2013
High RiskFDA
Aesculap, Inc.
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Surgical Devices·217 affected·Jul 16, 2013
High RiskFDA
Ormco/sybronendo
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchor...
Surgical Devices·4,786 affected·Jul 12, 2013
High RiskFDA
Precision Dynamics Corporation
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen...
Surgical Devices·1,200 affected·Jul 10, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is ...
Surgical Devices·9 affected·Jul 1, 2013
High RiskFDA
Alphatec Spine, Inc.
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correc...
Surgical Devices·333 affected·Jun 28, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgica...
Surgical Devices·215 affected·Jun 24, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical...
Surgical Devices·215 affected·Jun 24, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are inten...
Surgical Devices·99 affected·Jun 19, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating...
Surgical Devices·4 affected·Jun 19, 2013