MEDLINE 6016745541Recalls & reported problems
Medline Industries, Inc. · LHK,-,WUESTHOFF HEALTH SYSTEM,ROCKLEDGE · Class 2
Data updated Oct 13, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489179477), received between Jul 24, 2024 and Aug 5, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 27, 2026Open, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Connection Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2024Connection Problem; Connection Problem
IT WAS REPORTED THE CONTROL SYRINGE WOULD NOT "THREAD PROPERLY ONTO MANIFOLD" REQUIRING THEM TO "SWITCH OUT FOR ALL NEW MANIFOLD DURING PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19912611 ↗InjuryAug 5, 2024Connection Problem; Connection Problem
IT WAS REPORTED THE CONTROL SYRINGE WOULD NOT "THREAD PROPERLY ONTO MANIFOLD" REQUIRING THEM TO "SWITCH OUT FOR ALL NEW MANIFOLD DURING PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19912403 ↗MalfunctionJul 24, 2024Connection Problem; Connection Problem
IT WAS REPORTED THE CONTROL SYRINGE WOULD NOT "THREAD PROPERLY ONTO MANIFOLD" REQUIRING THEM TO "SWITCH OUT FOR ALL NEW MANIFOLD DURING PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822280 ↗
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. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. DYNJ51038RMedline Industries, Inc. · Cardiovascular procedure kit4 recalls2 reports
- Medline Industries, Inc. CDS983773JMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ42921GMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ50478FMedline 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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