Sklar Instruments 96-2549Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10649111056802), received between Jun 25, 2025 and Aug 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 3, 2024Open, Classified

   Reports of various packaging issues that may result in a breach of the sterile barrier.

   Z-0939-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2025, ONE OF SKLAR'S DISTRIBUTORS REACHED OUT TO CUSTOMER SERVICE REGARDING AN ISSUE WITH A HOLE IN THE STERILE PACKAGING OF 1 EA OF 96-2549 ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50. THIS WAS NOTED ON INCOMING INSPECTION. THE DEVICE WAS NOT USED ON ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730949 ↗
• MalfunctionJun 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON 6/23/2025, ONE OF SKLAR'S DISTRIBUTORS REACHED OUT TO CUSTOMER SERVICE REGARDING AN ISSUE WITH A HOLE IN THE STERILE PACKAGING OF 1 EA OF 96-2549 ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50. THIS WAS NOTED ON INCOMING INSPECTION. THE DEVICE WAS NOT USED ON ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331497 ↗