DeRoyal Industries Inc: Medical Device Recall in 2015 - (Recall #: Z-1642-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

Product Classification:

Class II

Date Initiated: April 17, 2015

Date Posted: May 27, 2015

Recall Number: Z-1642-2015

Event ID: 71193

Reason for Recall:

The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

Status: Terminated

Product Quantity: 5359 units

Code Information:

1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated