Medline Industries, Inc. DYNJ69705CRecalls & reported problems
Medline Industries, Inc. · SM OR-DR. YEH PACK-LF · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10198459164460), received between Aug 18, 2025 and Aug 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 12, 2025Class IIOpen, Classified
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Z-1193-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2025Material Fragmentation; Material Fragmentation
ACCORDING TO THE CUSTOMER, SMALL WHITE FRAGMENTS OF THE CLIP HOLDER MATERIAL HAVE BEEN COMING OFF WITH THE CLIP WHEN LOADED INTO THE CLIP APPLIERS SEVERAL TIMES. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THE SURGEON HAD TO REMOVE SMALL WHITE PIECES OF PLASTIC WITH FORCEPS FROM AN OPEN THYROIDECTOMY WOUND AFTER CLIP APPLICATION.
Patient problems: Foreign Body In Patient
MAUDE report 22826512 ↗
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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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