Z-0534-2018Class II

Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge

Name: Z-0534-2018 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge
Creator: Covidien LP
Published: 2017-07-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-07-17 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent... on 2017-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0534-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-17
Posted: 2018-02-08
Terminated: 2018-09-14
Recalling firm: Medtronic, Inc.
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 sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2017 to their customers via Federal Express or certified mail. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine, discontinue use and return affected product. Customers were instructed to acknowledge receipt of the Urgent Field Corrective Action Notice. For questions contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 33,280
Distribution: U.S., Gov Accts, and foreign countries: PA, PR, CO.
Product codes and lots: Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0534-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-08

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)