Telfa 80-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20749915001705), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 injury.

7 other recalls cover devices cleared under the same FDA submission (K904514); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026No Apparent Adverse Event

  DESCRIBE THE EVENT OR PROBLEM: COTTONOID COUNT WAS OFF WITH CLOSING COUNT. WENT THROUGH TRASH AND STERILE FIELD MULTIPLE TIMES. SURGEON REOPENED INCISION FOR A RELOOK. TOOK A C ARM PICTURE WITH NOTHING DETECTED. CALLED XR TECH FOR FLATPLATE IMAGE, AGAIN NOTHING WAS DETECTED. PLACED A COTTONOID ON PATIENT'S SKIN TO SEE IF XR WAS PICKING UP THE COTTONOID AT ALL AND IT WAS NOT VISIBLE IN THE IMAGE. PACKAGE STATES THESE COTTONOID STINGS ARE BARRIUM IMPREGNATED SO THEY SHOULD BE DETECTABLE IN XRAY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? NOT KNOWN. WHAT PROBLEM DID THE USER HAVE: OTHER. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K904514. One submission often covers many models, so check the product and lot details in each record.

• Z-1801-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1802-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1805-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1804-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1800-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1806-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Z-1803-2016 · Mar 31, 2016 · Terminated
  American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges