Medline Industries, Inc. DYNDB3086DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327313234), received between Aug 3, 2023 and Aug 3, 2023 — classified as 2 injuries.

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. Aug 11, 2026Class IOpen, Classified

   The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

   Z-3127-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jun 12, 2026Class IIOpen, Classified

   The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

   Z-3063-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE FACILITY "THE PROVIDER HAD AN ISSUE WITH BABIES BLEEDING WITH CLOTS AFTER USING THE DEVICE FOR CIRCUMCISION".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17450324 ↗
• InjuryAug 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE FACILITY "THE PROVIDER HAD AN ISSUE WITH BABIES BLEEDING WITH CLOTS AFTER USING THE DEVICE FOR CIRCUMCISION".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17450099 ↗