SPYRecalls & reported problems across all models
Stryker Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of SPY by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2023 and Sep 30, 2026 — classified as 1 injury, 51 malfunctions.
The most frequently reported specific device problem is “Fogging” (46 reports).
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
Reports received per month, all models
Most reported SPY problems
Device problems
- Fogging46
- No Display/Image5
- Optical Problem2
- Moisture or Humidity Problem1
- Poor Quality Image1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information2
SPY models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPY 0502538010Laparoscope, general & plastic surgery27 reports
- SPY 0502538030Laparoscope, general & plastic surgery14 reports
- SPY 0502538045Laparoscope, general & plastic surgery4 reports
- SPY 0502720030Endoscope, accessories, narrow band spectrum3 reports
- SPY 0502721030Cystoscope and accessories, flexible/rigid3 reports
- SPY 0502938010Laparoscope, general & plastic surgery1 report
Recent SPY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953980 ↗MalfunctionSep 28, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926188 ↗MalfunctionSep 25, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903905 ↗MalfunctionSep 25, 2026Fogging
It was reported that the scope was producing a blurred and foggy image, even after cleaning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898516 ↗MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876277 ↗MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876266 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862665 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862664 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862566 ↗MalfunctionSep 21, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848339 ↗MalfunctionSep 21, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848338 ↗MalfunctionSep 21, 2026Fogging
It was reported that the scope was cloudy and the cloudiness did not go off when cleaned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842492 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831234 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831062 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829436 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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