Medical Action Industries Inc: Medical Device Recall in 2019 - (Recall #: Z-0681-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.

Product Classification:

Class II

Date Initiated: November 27, 2018

Date Posted: January 2, 2019

Recall Number: Z-0681-2019

Event ID: 81640

Reason for Recall:

Potential compromise of product sterility due to breach of sterile barrier.

Status: Terminated

Product Quantity: 13 cases (2,600 sponges)

Code Information:

Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111

Distribution Pattern:

Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

Voluntary or Mandated:

Voluntary: Firm initiated