Kits contain leaking bottles of isopropyl alcohol
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Class I - Dangerous
Due to Titanium plasma coating not present implant.
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Abbott Laboratories
Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
Class I - Dangerous
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
Class I - Dangerous
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
MEDLINE INDUSTRIES, LP - SPT
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Intuitive Surgical
Class I - Dangerous
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Fresenius Medical Care Holdings
Class I - Dangerous
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Class I - Dangerous
The device may potentially cause a fire, leading to a safety risk.
Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Stryker Instruments
Class I - Dangerous
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Class I - Dangerous
Device was marketed without FDA 510(k) clearance or a PMA.
Kits contain leaking bottles of isopropyl alcohol
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
MEDLINE INDUSTRIES, LP - SPT
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
Class I - Dangerous
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.