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BD has identified internally that the infusion sets contain di(2-ethylhexyl) phthalate (DEHP) and have not been labeled accordingly. Recall start date: November 13, 2023

BD has identified internally that the infusion sets contain di(2-ethylhexyl) phthalate (DEHP) and have not been labeled accordingly. Recall Start Date: October 12, 2023

Medline recalls sterile 4.5" iris scissors (dynj04049); tip protector may detach, risking unseen punctures in the sterile barrier. Recall start date: August 11, 2023

The packaging containing a pair of sterilized surgical gloves is not sufficiently sealed potentially compromising the sterility assurance of the product. Recall start date: August 3, 2023

Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of Trigen Trochanteric Antegrade nail due to a packaging error. Recall start date: July 24, 2023

Smith & Nephew Medical Limited has initiated a field action to voluntarily remove certain batches of no-sting skin-prep wipes and no-sting skin-prep swabs due to a manufacturing error resulting in the presence of acetic acid causing a vinegar-like…

Potential of the luer connection portion of the dilator hub to crack or dislodge during use on certain tearaway sheath introducer assemblies. The potential for the luer connection of the dilator hub to crack or dislodge is due to improper storage…

Stryker has identified a nonconformance in a specific lot of Aequalis® Flex Revive® Assembly Screws. Specifically, a comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis® Flex Revive® Assembly Screws 0mm…

Stryker has determined that size 11 (11mm) height peek Ogival Interbody Cage (OIC) was incorrectly laser marked as having a size 10 (10mm) height. Recall start date: May 19, 2023

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning…

During internal testing, regulatory compliance issues regarding fluid ingress and basic safety issues have been identified with the Tempus Pro monitor, ac mains power supply, and the vehicle adaptor. the tempus pro device's labeling indicates that the…

Stryker has identified that there is a potential that the affected device was shipped with the incorrect language configuration. Recall start date: January 26, 2023

Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module…

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…

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.…