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Displaying 1 - 15 of 4476 items.
Equate Vitamin D Droplets Kids: incorrect outer carton
The affected lot is packaged with the incorrect outer carton.
RecallHealth product recall | 2024-03-18
Medfusion Syringe Infusion Pumps
Smiths Medical is issuing this letter to notify customers not to use Cardinal Health branded Monoject syringes with Medfusion 3500 and 4000 Syringe Pumps. On September 20, 2023, Cardinal Health issued a medical device product correction for the Cardinal…
RecallHealth product recall | 2024-03-14
Patient Information Center iX
It was found that the care assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when ios device screens were locked with a passcode. The issue occurred on devices running IOS 15, 16 and 17 as well as multiple versions of…
RecallHealth product recall | 2024-03-14
Perseus A500
The recall is being initiated as the market surveillance activities revealed a few cases in which the internal backup battery failed spontaneously while the perseus device being operated without mains supply. This resulted in an unexpected shutdown of…
RecallHealth product recall | 2024-03-14
Trident II Clusterhole HA Acetabular Shell
Stryker has discovered a potential issue with Trident II Hemispherical and PSL shells where the acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
Recall Start Date: February 27, 2024
RecallHealth product recall | 2024-03-13
Auto Suture Blunt Tip and Structural Balloon Trocar
Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar…
RecallHealth product recall | 2024-03-13
MIS Sterile Instrument Pack
Stryker has identified a nonconformance within specific lots of the beaver blade handle. The beaver blade handle does not tighten to the beaver blade (surgical scalpel) as intended.
Recall Start Date: March 5, 2024
RecallHealth product recall | 2024-03-13
Clip Applier
The recall was initiated due to an increase in clip applier complaints as the units form these lots have the potential to result in a clip not loading into the jaws after the trigger is actuated.
Recall Start Date: January 26, 2024
RecallHealth product recall | 2024-03-13
FOLIC ACID 1MG - Affected lots exceed or may exceed the acceptable intake limit for N-nitroso-folic acid.
Affected lots exceed or may exceed the acceptable intake limit for N-nitroso-folic acid.
RecallHealth product recall | 2024-03-12
Various Olympus Medical Endoscopes
As a result of catch up 510(k)s on the subject devices, the reprocessing instructions were changed. Specifically, the EtO gas mixture was revised to reflect the gas mixture that is commercially available and optionable reusable brushes were removed as a…
RecallHealth product recall | 2024-03-12
Cardinal Health Cardiovascular, Bypass and Hepatobiliary Packs
The recent expansion to medical device recall from Medtronic/Covidien concerning various sutures found in some Cardinal Health Presource® kits. Specific lots of these sutures were sterilized with gamma doses that exceed the range approved or were exposed…
RecallHealth product recall | 2024-03-12
Digital Radiography Mobile X-Ray System Dx-D 100
A component supplier of the Agfa Dx-D 100 informed Agfa about a potential safety issue. The issue as described by the supplier is related to the steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube…
RecallHealth product recall | 2024-03-12
Impella Products
New warnings are being added to the instructions for use for affected products to reduce the possibility of fibers being drawn into the Impella pumps, which may result in low flow of the device.
Recall Start Date: February 26, 2024
RecallHealth product recall | 2024-03-12
Baxter Flo-Thru, Flo-Rester and Vascular Probe
Baxter is issuing an important product information letter to communicate that the surgical tools education deck (ref ca-as20-220001) that may have been presented for the products listed, contains inaccurate content that does not align with the products'…
RecallHealth product recall | 2024-03-08
Parapac Plus 310 Ventilators
When a Parapac Plus™ ventilator is switched to the operating mode of 'ventilate', Parapac Plus™ ventilators may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non‐cycling and continuous…
RecallHealth product recall | 2024-03-08