Loading...
Loading...
All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Daimler Coaches North America (Daimler Coaches) is recalling certain 2011-2016 Setra S417 TC and 2012-2016 Setra S 407 CC vehicles equipped with a Ricon wheelchair lift. The red beacon lighting on the Threshold Warning System (TWS) may not be bright enough. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 403, "Platform Lift Systems."
This recall involves Gasaciods children's multi-purpose helmets, fitting a head circumference of about 19-1/2 to 20-1/2 inches. The helmets were sold in pink and blue, with red removable padding, black straps, and a black and red buckle. The helmets have a red plastic knob at the back of the helmet with a LED warning light for adjusting the fitting. "GASACIODS" is printed on the sides of the helmet.
This recall involves 750mL and 1500mL sizes of Randder 2-Pack Liquid Fuel Bottles. The bottles are red with a black cap, and bear white markings or text including, "RANDDER", "fuel bottle", "fill level", warnings and/or directions, a logo, and the bottle's volume.
This recall involves Full Speed Ahead's Gossamer Pro AGX+ bicycle cranksets, model CK-6037. They were sold separately and on bicycles including Cannondale, Canyon, Marin, Haro, Fuji, and Pinarello gravel brands. "FSA Gossamer Pro" is etched on the front of the crankarm. The model and serial numbers can be found on the back of the bicycle's crankarm, next to the pedal threads. Only serial numbers beginning with B1, B2 or B3 are included in this recall.
Jaguar Land Rover North America, LLC (Jaguar) is recalling certain 2021-2023 E-Pace vehicles. The passenger air bag may tear during deployment.
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
Potential contamination of the product with latex adhesive residual.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
The guide tip can become damaged and result in the tip detaching.
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. 1010.2 in that they currently do not bear the required certification label.
Spencer Manufacturing, Inc. (Spencer) is recalling certain 2024 Pumper vehicles equipped with Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware may fail to shut off the output pin, resulting in overloaded electrical circuits.