Agency classClass IIOur severity:High FDA (Devices)·Z-0534-2018·Announced 2018-02-14

Medtronic Recalls Vistec X-Ray Detectable Sponges Due to Blood Contamination

Medtronic is voluntarily recalling two lots of Vistec X-Ray Detectable Sponges due to possible contamination with human blood during manufacturing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (human blood) in a medical device without reported illnesses, fitting the criteria for a High severity score.

Plain-English summary

Medtronic is voluntarily recalling two production lots of its Covidien Vistec X-Ray Detectable Sponges. The recall is due to possible contamination with human blood, which may have occurred during the handling of the product in the manufacturing process prior to final packaging and Ethylene Oxide sterilization.

The affected product consists of medical absorbent devices intended for internal use within the body cavity to control bleeding or apply medication. The sponges feature dual-colored elements, including a blue radiopaque strand and a white strand visible when saturated with blood. The specific lot numbers involved are 17E121362 and 17E121262, with UDIs 10884527016990 and 20884527016997.

A total of 33,280 units were distributed to U.S. government accounts and foreign countries, including Pennsylvania, Puerto Rico, and Colorado. Healthcare facilities and users should check their inventory for these specific lot numbers and discontinue use of the affected sponges.

The recalled product

Product: 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…
Manufacturer: Covidien LP
Category: Medical Device — Surgical Sponges
Hazard: blood-contamination
infection-risk
Affected units: 33,280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot Numbers: 17E121362
17E121262 UDI: 10884527016990
20884527016997

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Covidien LP

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · blood contamination