Search

Stryker is notifying airo truct customers that we will be highlighting certain information that is already in the airo truct user manual on labels affixed to the airo truct unit itself. Stryker received one report of an injury to an untrained user that…

Unsealed edge of blister package containing individual GLC devices. Device may not meet label claims for sterility. One complaint has been reported with the unsealed edge of the blister package containing individual GLC devices. There were no adverse…

This recall addresses a product concern regarding the drapes in the kit. The supplier (3M) decided to recall the drapes in the kit because it was confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without…

Medline Industries, lp is issuing a safety alert for custom procedure packs containing sterile blades due to the potential of the blade puncturing the outer foil layer of the sterile packaging. Recall start date: November 21, 2022

Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on radiographic imaging. Infolding is different and distinct…

Multiple complaints for the TON3015 were received for "needle protector fully dislodged / hole in pouch" due to exposed sharp. Recall start date: August 10, 2021

Complaint reports indicate there is a possibility the 8mm reamer in AR-8981-08s may measure 6mm, and the 6mm reamer in AR-8981-06s may measure 8mm.  Recall start date: November 2, 2022

The Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions.…

Cardinal Health is issuing this correction to make you aware of a labeling update on its reusable hot and cold gel pack products. Specifically, a caution statement is being added to ensure the products are not used on infants or neonates. Recall start…

Zimmer Biomet is conducting a lot specific medical device recall for of various G7 acetabular shells and liner due the outer sterile cavity having the potential to be below the minimum wall thickness. The thin corner wall could potentially crack during…

Manufacturer initiated recall notifying users of lot-specific open vial stability claim reduction = IFU correction to affected lots. Open vial stability for troponin I present in OCRD-UL, OCRD-I and OCRD-SP does not meet the 15 day claim in IFU. Analysis…

The affected masks contain magnets which can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic fields. Recall start date: September 15, 2022

Baxter Corporation is issuing an urgent medical device correction for the Prismaflex sets listed. The current Prismaflex set IFU is a single booklet containing 27 translated languages, and the following products include a mistranslation in the Estonian (…

The rounded tip can detach from the shaft which could be left behind in the the treated area or aspirated. Recall start date: September 7, 2022

Stryker has identified a nonconformance within two specific lots of evolve proline stems. Specifically, the outer label does not match the device inside the package. the affected lot of evolve proline stem 7.5mm +2 contains a size 9.5mm +4 stem, while…