HALYARD Laparoscopy Comprehensive Pack II
Laparoscopy packs labeled as latex free contain a latex urethral catheter.
Medical device recalls
Medical device recalls from FDA, newest first.
2 recalls
Medical Action Industries Kit: Urinary Clean Catch 20/cs
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
2 recalls
Expressaire and ASP Global Disposable Tourniquet Cuffs
Disposable Tourniquet Cuffs have an incorrect expiration date, as they are labeled with a 10-year shelf life instead of the validated 5 years.
64 products
Karl Storz HOPKINS Telescopes
Hopkins telescopes have an incorrect inside packaging label for the eyepiece.
2 recalls
Pipeline Flex Embolization Device with Shield Technology
The Pipeline Flex Embolization Device with Shield Technology has incorrect label dimensions, being 2.50 mm instead of 3.00 mm.
Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits
Reason given by FDA: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure.
7 products
1 recall
Baxter Pro+ MRS Surfaces for VersaCare
PRO+ MRS Surface for Versacare has an error in its UDI label that may lead to incorrect product identification.
3 products
1 recall
ForeSight Elite Tissue Oximetry Cable
The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.
2 recalls
Olympus EZDilate Endoscopic Balloon Dilators
Reason given by FDA: Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm.
1 recall
B Braun Medical Discofix Four Way Stopcock Extension Sets
The Discofix Four WAY Stopcock has an incorrect expiration date printed on the carton shipper label.
1 recall
Olympus POWERSEAL Curved Jaw Sealer & Divider
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2 recalls
Halyard Total Joint and DaVinci TruCustom Bundles
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
8 products
Medline Trach Tube Kit
The Medline medical convenience kit labeled as Trach Tube Kit has a component labeling discrepancy.
1 recall
Straumann Bone Level Tapered (BLT) Implant
The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.
1 recall
Straumann GM Helix Dental Implants
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.
2 recalls
Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration before the end of their shelf life.
4 products
GORE VIABIL Short Wire Biliary Endoprosthesis
The GORE VIABIL biliary endoprosthesis may be mislabeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.
2 products
2 recalls
TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices
Currently labeled shelf life of 36 months is not substantiated by real-time data.
8 products
Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis
The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.
2 products
1 recall
Terex Utilities Power Over Fiber Base Module
The Power Over Fiber Base Module is not certified and is improperly labeled.
1 recall
Pipeline Flex Embolization Device with Shield Technology
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
4 products
1 recall
Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters
Farastar ablation generators and catheters have labeling that does not include Farapoint PFA catheter information.
3 products
1 recall
Orthofix Minirail External Fixation Devices
Unilateral external fixation devices may be incorrectly labeled.
4 products
2 recalls
BD Medline 111 Gravity Set
The gravity set was shipped as an engineering sample labeled not for human use.
Covidien Shiley Disposable Decannulation Plug
The Covidien Shiley Disposable Decannulation Plug has incorrect labeling that includes a symbol for non-DEHP, but the product contains DEHP.
1 recall
Philips Telemetry Monitor 5500 1.4 GHz
The Philips Telemetry Monitor 5500 1.4 GHz may reset to a default state, causing loss of configuration and failure to reconnect.
1 recall
Inspire Respiratory Sensing and Stimulation Lead
The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.
2 products
1 recall
Howmedica Osteonics Tri TS Baseplate
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
2 products
1 recall
DirectCHECK ACT-LR Whole Blood Quality Control, Level 2
The whole blood quality control has labeling with an incorrect performance range.
1 recall
Fresenius Medical Care Holdings Bicarby Dialysate
Bicarby Dialysate has an error in the labeling of the GTIN, which may lead to unrecognized use of a potassium solution with a differing concentration.
1 recall
DT MedTech Hintermann Series Talar Implant
The Hintermann Series Talar Implant, Left, Size 2 has incorrect packaging labeling a right implant device.
1 recall
NeoSpan SuperElastic Compression Staple w/Instruments
The NeoSpan SuperElastic Compression Staple w/Instruments is missing the Magnetic Resonance Conditional Symbol on its packaging and labels.
2 recalls
Mahurkar Elite PASS Trays
Mahurkar Elite PASS Trays are missing the Tegaderm CHG dressing specified in product labeling.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves
The blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
2 recalls
SSC- Surgical Specialties Sharpoint Microsurgical Knife
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Grace Medical Stapes Prosthesis
The stapes prosthesis has incorrect functional length on its labeling.
1 recall
Advanced Bionics HiResolution Bionic Ear System Cochlear Implants
The HiResolution Bionic Ear System has an incorrect shelf-life expiration date.
1 recall
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula
The Shiley Tracheostomy Tube has incorrect display box labeling.
2 recalls
Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation
The Medtronic Pocket Adaptor Kits are labeled with incorrect Use-By-Dates.
2 products
Medline Eye Tray-LF Medical Convenience Kit
The Medline Eye Tray-LF kit contains syringes labeled as 1 mL but are U-100 insulin syringes.
1 recall
HydroMARK Breast Biopsy Site Marker
The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.
1 recall
RelayPro Thoracic Stent-Graft System
The RelayPro Thoracic Stent-Graft System may have a proximal clasp disconnection that prevents release from the delivery system.
2 recalls
Omnicell I.v.Station Syringe Labels
Rolls of label stock used with the Omnicell i.v.Station may cause mislabeled syringes.
Edwards EVOQUE Tricuspid Delivery System
The Edwards EVOQUE tricuspid delivery system has a labeling update to warn if its function is compromised.
1 recall
Centinel Spine Prodisc C SK Total Cervical Disc Replacements
The Prodisc C SK U.S. Implant Extra Large 5mm and 6mm have a labeling mix-up.
2 products
1 recall
Diversatek Healthcare Viper 3-Stage Fixed Wire and Wire Guided Balloon Dilator
The balloon dilator's inflation tag may list incorrect balloon sizes and pressures.
4 products
1 recall
nanOss 3D Advanced Bone Graft Substitute
The bone graft substitutes were incorrectly labeled with a 5-year shelf life instead of the approved four years.
1 recall
Cook Medical Guide Wires, Catheter Sets and Trays
Cook Medical devices were labeled with expiration dates that exceed their true shelf life.
18 products
2 recalls
XTANT Medical Xpress Pedicle Screw System
The Xpress Pedicle Screw System was mislabeled with an incorrect part number, identifying it as shorter than it is.
