DAYSPRING F-0050-02Recalls & reported problems
Koya Medical, Inc. · LOWER LEG GARMENT · Class 2
Data updated Oct 18, 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 00850012532736), received between May 12, 2026 and May 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Impaired Healing1
- Peripheral Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Improper or Incorrect Procedure or Method
A NURSE FROM A HEALTHCARE FACILITY CALLED KOYA MEDICAL SALES REP STATING THAT A DAYSPRING USER'S FEET WERE SWOLLEN. SALES REP WENT TO THE USER'S HOME AND ASKED THE USER TO DEMONSTRATE HOW HE USES THE DAYSPRING DEVICE. IT WAS DISCOVERED THAT THE USER HAS BEEN PUTTING THE DEVICE ON UPSIDE DOWN SINCE JANUARY 2026. THE USER'S FEET WERE NOW TOO BIG TO FIT INTO A FOOT WRAP OR THE SOCKS PROVIDED WITH THE DAYSPRING KIT. HIS LEGS WERE WRAPPED FROM WOUND CARE AND HE WORE COMPRESSION WRAPS OVER THE WOUND CARE WRAPS. THE SALES REP NOTED THE USER HAD TWO WOUNDS, ONE ON EACH LEG.
Patient problems: Impaired Healing; Peripheral Edema
MAUDE report 25151314 ↗
Other SLEEVE, LIMB, COMPRESSIBLE devices
- Kendall 84021Cardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE2 recalls0 reports
- Kendall SCD 29525Cardinal Health, Inc. · Sleeve, Limb, Compressible56 reports
- RAW MATERIAL 30MDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE52 reports
- Kendall 84021PCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- Kendall 84021BCardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
- AIRCAST 3011-PLDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page