PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Ethicon Endo Surgery
🏥 Medical Devices Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The potential for cracks forming in the breathing circuit hose.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Stryker
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
🏥 Medical Devices Class I - Dangerous
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Stryker Spine
🏥 Medical Devices Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
🏥 Medical Devices Class I - Dangerous
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
🏥 Medical Devices Class I - Dangerous
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Qiagen Sciences
🏥 Medical Devices Class I - Dangerous
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
🏥 Medical Devices Class I - Dangerous
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
🏥 Medical Devices Class I - Dangerous
The potential for cracks forming in the breathing circuit hose.
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.