CARDINAL HEALTH K87Recalls & reported problems
Cardinal Health 200, LLC · Yankauer Suction Handle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885380030164), received between Jan 28, 2021 and Aug 24, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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, 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
- Break4
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50412637 ↗MalfunctionMay 13, 2025Break; Break
THE CUSTOMER REPORTED THAT YANKAUER OPEN TIP BROKE OFF DURING SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT IT WAS UNKNOWN IF THERE WAS ANY PIECE LEFT INSIDE THE PATIENT AND IT WAS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION OR TREATMENT REQUIRED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22008892 ↗MalfunctionMay 1, 2023Break; Break
THE CUSTOMER REPORTED THAT UPON INSPECTION OF OUR WAREHOUSE PERSONNEL, THEY FOUND OUT THAT CAT. NO. K87 HAS (B)(4) DAMAGED PACKAGES WITH TWISTED AND BROKEN PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16845450 ↗InjuryJan 28, 2021Break; Break
THE CUSTOMER REPORTED AFTER SUCTIONING, THE TECH NOTICED THE TIP BROKE OFF WHILE IN USE IN THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE TIP FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11243029 ↗
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- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- CRD 65651-517Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 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.
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