Covidien LP: Medical Device Recall in 2018 - (Recall #: Z-0534-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.

Product Classification:

Class II

Date Initiated: July 17, 2017

Date Posted: February 14, 2018

Recall Number: Z-0534-2018

Event ID: 78968

Reason for Recall:

Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.

Status: Terminated

Product Quantity: 33,280

Code Information:

Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997

Distribution Pattern:

U.S., Gov Accts, and foreign countries: PA, PR, CO.

Voluntary or Mandated:

Voluntary: Firm initiated