Medline Industries, Inc. DYNJ54762DRecalls & reported problems
Medline Industries, Inc. · RADIOLOGY PACK · Class 2
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327031725), received between Aug 12, 2026 and Aug 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Recalls naming this device
- Feb 27, 2026Class IIOpen, Classified
Unapproved design changes to the products outside of the 510(k) clearance.
Z-1878-2026 · Root cause: Component change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Break
It was reported that "tip broke on the scissors in rad pack."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254698 ↗MalfunctionAug 12, 2026Material Frayed
It was reported that OR towels are linting heavily.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221210 ↗
Other Cardiovascular procedure kit devices
- Medline Industries, Inc. CDS840396YMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS983513FMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. DYNJ51038RMedline Industries, Inc. · Cardiovascular procedure kit4 recalls2 reports
- NAMIC 60033123Medline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ905079FMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ0376608OMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 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 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