All Recalls

95,083 total recalls in our database

various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Table 722020; Allura Xper FD10 OR Table 722022; Allura Xper FD20 OR Table 722023; Allura Xper FD10/10 OR Table 722024; Allura Xper FD20 Biplane OR Table 722025; Allura CV20 722031

Philips Electronics North America

🏥 Medical Devices Class I - Dangerous

Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

Mar 22, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

Hemotherm CE, model 400CE, Heater-Cooling Device

Cincinnati Sub-Zero Products

🏥 Medical Devices Class I - Dangerous

Improperly rated fuses were used in the manufacture of the device.

Mar 9, 2017 Other Medical Devices Nationwide View Details →

Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

Laerdal Medical

🏥 Medical Devices Class I - Dangerous

The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

Jan 8, 2017 Other Medical Devices Nationwide View Details →

Tapered SwissPlus Implant System, Model No. SPB10

Zimmer Dental

🏥 Medical Devices Class I - Dangerous

It was manufactured with the minor diameter of the internal thread that is below specification.

Mar 20, 2017 Implants & Prosthetics View Details →

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Mar 15, 2017 Other Medical Devices Nationwide View Details →

various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Signal Medical

🏥 Medical Devices Class I - Dangerous

Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.

Feb 20, 2017 Other Medical Devices Nationwide View Details →

Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Alcon Research

🏥 Medical Devices Class I - Dangerous

Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.

Mar 27, 2017 Other Medical Devices Nationwide View Details →

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Cook

🏥 Medical Devices Class I - Dangerous

Product may overheat, melt, and burn patient.

Mar 7, 2017 Surgical Instruments View Details →

Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.

Avid Medical

🏥 Medical Devices Class I - Dangerous

Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed component lots were contained in product 519700 component case. This occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. This issue was immediately contained and corrected. A full inventory analysis was conducted reviewing all vacutainer component inventories. The issue was found to affect a total of five vacutainer components.

Mar 15, 2017 Diagnostic Equipment View Details →

UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039

Philips Electronics North America

🏥 Medical Devices Class I - Dangerous

Mar 22, 2017 Other Medical Devices Nationwide View Details →

Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Medical

🏥 Medical Devices Class I - Dangerous

The stopcock was found to have punctures.

Feb 2, 2017 Diagnostic Equipment Nationwide View Details →