Electrode, Needle
FDA adverse event reports and recall history for electrode, needle (product code GXZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 326
- Deaths
- 0
- Injuries
- 107
- Malfunctions
- 208
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-09-03TerminatedProcess control
21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- 2010-09-03TerminatedProcess control
17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
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