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Medline SPEC0240Recalls & reported problems

Medline Industries, Inc. · PQ BIOPSY PACK (BPGSG) · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277524897), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryDec 9, 2021Break

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A PROCEDURE AND A PIECE OF THE HEMOSTAT BROKE OFF IN THE PATIENT'S SKIN. THE PIECE OF THE HEMOSTAT WAS SAFELY REMOVED (PROCESS OF REMOVAL NOT REPORTED) AND THERE WAS NO FURTHER IMPACT NOTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 12967474 ↗

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Sources and updates

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