MicroMyst 205000DSRecalls & reported problems
Integra Lifesciences Corporation · MicroMyst Applicator (14cm) 5 pack - for use with Flow Regulator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780000112), received between Feb 6, 2025 and Jun 20, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- May 23, 2025Open, Classified
Lack of sterility assurance.
Z-1961-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Obstruction of Flow1
Patient problems
- Unspecified Infection3
- Post Operative Wound Infection2
- 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.
InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3003418325-2025-00026; 3003418325-2025-00027; 3003418325-2025-00028. A FACILITY RETURNED A VOLUNTARY MEDICAL DEVICE RECALL LETTER AND INDICATED THAT THEY ARE INVESTIGATING FOUR MICROMYST APPLICATOR BOX OF 5 (205000DS) WITH KNOWN INFECTIONS AFTER USE OF THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Post Operative Wound Infection; Unspecified Infection
MAUDE report 22302438 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3003418325-2025-00026; 3003418325-2025-00025; 3003418325-2025-00027. A FACILITY RETURNED A VOLUNTARY MEDICAL DEVICE RECALL LETTER AND INDICATED THAT THEY ARE INVESTIGATING FOUR MICROMYST APPLICATOR BOX OF 5 (205000DS) WITH KNOWN INFECTIONS AFTER USE OF THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Post Operative Wound Infection; Unspecified Infection
MAUDE report 22302437 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS 1 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3003418325-2025-00025, 3003418325-2025-00027, 3003418325-2025-00028. A FACILITY RETURNED VOLUNTARY MEDICAL DEVICE RECALL LETTER AND INDICATED THAT THEY ARE INVESTIGATING FOUR MICROMYST APPLICATOR BOX OF 5 (205000DS) WITH KNOWN INFECTIONS AFTER USE OF THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 22302435 ↗MalfunctionFeb 6, 2025Obstruction of Flow; Obstruction of Flow
Other Syringe, Piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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