Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled ...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Conmed Corporation
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT...
Surgical Devices·1,612,440 affected·Jun 19, 2017
High RiskFDA
Custom Assemblies Inc
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Cu...
Surgical Devices·2,155 affected·Jun 15, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1...
Surgical Devices·214 affected·Jun 7, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty proc...
Surgical Devices·426 affected·Jun 7, 2017
High RiskFDA
C.r. Bard, Inc.
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in t...
Surgical Devices·2,350 affected·Jun 2, 2017
High RiskFDA
Master & Frank (pinghu) Co., Ltd.
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit w...
Surgical Devices·2,160 affected·Jun 1, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate c...
Surgical Devices·10 affected·Jun 1, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Surgical Devices·32 affected·Jun 1, 2017
High RiskFDA
Arrow International Inc
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short o...
Surgical Devices·0 affected·Jun 1, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rota...
Surgical Devices·100 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, ste...
Surgical Devices·1,100 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Prod...
Surgical Devices·120 affected·May 30, 2017
High RiskFDA
Icu Medical, Inc.
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a...
Surgical Devices·50 affected·May 30, 2017
High RiskFDA
Elekta, Inc.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target ...
Surgical Devices·2 affected·May 23, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical i...
Surgical Devices·453 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surg...
Surgical Devices·418 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.
Surgical Devices·30 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
Surgical Devices·2 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical inst...
Surgical Devices·3,640 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surg...
Surgical Devices·240 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical in...
Surgical Devices·1,091 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
Surgical Devices·25 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instr...
Surgical Devices·1,286 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic sur...
Surgical Devices·4 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instr...
Surgical Devices·389 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. or...
Surgical Devices·10 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrum...
Surgical Devices·27 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
Surgical Devices·15 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.
Surgical Devices·2,240 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonster...
Surgical Devices·198 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
Surgical Devices·155 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgi...
Surgical Devices·25 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic su...
Surgical Devices·198 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
Surgical Devices·2,585 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.
Surgical Devices·236 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical i...
Surgical Devices·1,129 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.
Surgical Devices·356 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. o...
Surgical Devices·173 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
Surgical Devices·150 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.
Surgical Devices·439 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.
Surgical Devices·1,550 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
Surgical Devices·224 affected·May 22, 2017
High RiskFDA
Cryolife, Inc.
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Surgical Devices·705 affected·May 19, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fair...
Surgical Devices·2,910 affected·May 17, 2017
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Surgical Devices·73,796 affected·May 17, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable P...
Surgical Devices·27,485 affected·May 9, 2017