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ACCULIF 800257Recalls & reported problems

Stryker Corporation · SYRINGE PLUNGER · Class 2

All models of ACCULIF (15)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327067101), received between Mar 9, 2016 and Mar 9, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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

  • Activation Failure1
  • Device Operates Differently Than Expected1
  • Material Deformation1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 9, 2016Material Deformation; Material Integrity Problem; Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem; Activation Failure

    IT WAS REPORTED THAT: THREADING THE PLUNGER INTO THE SYRINGE. THE PLUNGER WAS SKIPPING THREADS ON PEEK PORTION OF INSERTER. THE CAGE WOULD NOT EXPAND AT ALL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5490029 ↗

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Sources and updates

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