MEDLINE DYNDH1699Recalls & reported problems
Medline Industries, Inc. · BIOPSY PACK · 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 10653160349914), received between Feb 10, 2023 and Feb 10, 2023.
The most frequently reported specific device problem is “Crack” (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.
Recalls naming this device
- May 21, 2026Class IIOpen, Classified
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Z-2542-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack1
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.
No answer providedFeb 10, 2023Crack
A CRACKED SPECIMEN VIAL FOUND IN ULTRASOUND BIOPSY KIT. VIAL REMOVED, NO HARM OR DELAY TO PATIENT CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16351088 ↗
Other TRAY, SURGICAL devices
- Centurion MNS11625Centurion Medical Products Corporation · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDA2526Medline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDH1470BMedline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYNDH1534Medline Industries, Inc. · TRAY, SURGICAL3 recalls0 reports
- MEDLINE DYKM1790AMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- Centurion ART245ACenturion Medical Products Corporation · TRAY, SURGICAL2 recalls0 reports
- MEDLINE DYNDC1786AMedline Industries, Inc. · TRAY, SURGICAL2 recalls0 reports
- MEDLINE ART970Medline Industries, Inc. · TRAY, SURGICAL2 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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