Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
ARTIS icono ceiling. Model Number: 11328100.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Ca...
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
CRE Pro Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 ...
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845220...
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B96...
A single lot of expired syringes were distributed due to a distribution system control failure.
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers...
Due to catheter separation
CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: AR...
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HA...
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
CRE Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator...
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS ...
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun...
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5...
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro...
Potential for thrombus formation during prolonged use of the introducer.
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephi...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide ...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).