Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Smith & Nephew Medical
Class I - Dangerous
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class I - Dangerous
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
Intera 1.5T Master/Nova, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T CX, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Fresenius Kabi USA
Class I - Dangerous
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Class I - Dangerous
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Class I - Dangerous
The product does not meet sterility assurance level.
Class I - Dangerous
Medical device components were marketed without FDA clearance
Chromophare Surgical Light System , REF CH00000001
Stryker Communications
Class I - Dangerous
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Human Care Hc Sweden Ab
Class I - Dangerous
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Microbiologics
Class I - Dangerous
The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Intuitive Surgical
Class I - Dangerous
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Class I - Dangerous
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration