Medline-Microtek Surgical Slush - Hush-Slush Drape (REF ORS-330N)Recalls & reported problems
Microtek Medical LLC · Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 in x 66 in) · Class 2
Data updated Oct 18, 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 10748426140463), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Material Puncture/Hole; Material Puncture/Hole
THE FACILITY REPORTED THAT A SLUSH DRAPE FROM A VALVE PACK LEAKED DURING A SURGICAL PROCEDURE. A HOLE WAS DISCOVERED AT THE END OF THE CASE WHEN THE DRAPE WAS REMOVED FROM THE WARMER, REVEALING SALINE AND SURGICAL CONTENTS POOLED AT THE BOTTOM OF THE MACHINE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION PER THE SURGEON AND ANESTHESIA TEAM'S RECOMMENDATION. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538724 ↗
Other Drape, Surgical, Exempt devices
- Medline DYNJP3102AMedline Industries, Inc. · Drape, surgical, exempt3 recalls2 reports
- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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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