AMD-RITMEDRecalls & reported problems across all models

We found 3 models of AMD-RITMED by AMD Medicom Inc in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AMD-RITMED recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 8, 2026Open, Classified

   Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

   Z-2459-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. May 8, 2026Open, Classified

   Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

   Z-2458-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported AMD-RITMED problems

AMD-RITMED models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMD-RITMED 85995C

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 recall0 reports
• AMD-RITMED 55992C

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 recall0 reports
• AMD-RITMED 1501-ROLL

  GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
  1 report

Recent AMD-RITMED adverse event reports

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

• MalfunctionOct 20, 2020Material Integrity Problem; Material Integrity Problem

  A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 28-AUG-2020 FOR AMD-RITMED LAPAROTOMY SPONGE ITEM CODE 1501-ROLL LOT# 81043-1. THE LAPAROTOMY SPONGE IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE GDY. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED "LINT ON OVERHEAD TABLE COVER AND INSTRUMENTS. LINT ON LIVER DURING PROCEDURE" THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706696 ↗