Resource Optimization & Innovation Llc: Medical Device Recall in 2017 - (Recall #: Z-1574-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU

Product Classification:

Class II

Date Initiated: January 9, 2017

Date Posted: April 5, 2017

Recall Number: Z-1574-2017

Event ID: 76255

Reason for Recall:

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Status: Terminated

Product Quantity: 704 kits

Code Information:

026598A Exp Date 2017-06-30; 028130A Exp Date 2017-07-30; 028918A Exp Date 2017-01-30; 029122A Exp Date 2017-09-30; 029906A Exp Date 2017-10-30; 031960A Exp Date 2018-01-30; 033019A Exp Date 2018-04-30;

Distribution Pattern:

US Distribution to LA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated