Medline Industries, Inc. DYNDH1738ARecalls & reported problems
Medline Industries, Inc. · BLOOD CULTURE BOTTLE KIT · Class 1
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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327239848), received between Sep 14, 2026 and Sep 14, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Dec 21, 2023Class IIOpen, Classified
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
Z-0964-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
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.
MalfunctionSep 14, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that "We had two bottles that when we tried to pierce the bottle to work up a positive blood culture the stopper detached and pushed further into the bottle." It was also reported that "about 3 weeks ago they received a blood culture set where the grey stopper had come off and the bag was filled with blood."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752804 ↗
Other Blood and urine collection kit (excludes HIV testing) devices
- Medline Industries, Inc. DYNDH1622CMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)4 recalls0 reports
- Medline Industries, Inc. DYNDH1462BMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)3 recalls0 reports
- Medline Industries, Inc. DYNDH1714AMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)3 recalls0 reports
- Medline Industries, Inc. DYNDH1723Medline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)3 recalls0 reports
- Medline Industries, Inc. DYNDH1866Medline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)3 recalls0 reports
- Medline Industries, Inc. DYNDH1694AMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)3 recalls0 reports
- Medline Industries, Inc. DYNDB3086DMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)2 recalls2 reports
- Medline Industries, Inc. DYNDH1708AMedline Industries, Inc. · Blood and urine collection kit (excludes HIV testing)2 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.
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