Windstone Medical Packaging, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1621-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Product Classification:

Class II

Date Initiated: April 24, 2023

Date Posted: May 31, 2023

Recall Number: Z-1621-2023

Event ID: 92288

Reason for Recall:

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Status: Ongoing

Product Quantity: 60 kits

Code Information:

Lot 188843; UDI: B098AMS4601E0

Distribution Pattern:

US: MA OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated