MEDLINE INDUSTRIES, INC. DYNJT4945Recalls & reported problems
Medline Industries, Inc. · LAPAROSCOPY PACK CSM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10198459459344), received between Dec 29, 2025 and Dec 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
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
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
MalfunctionDec 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 AS A RAYTEC WAS PULLED OUT OF THE ABDOMEN "THROUGH AN 8MM ROBOTIC PORT WITH AN 8MM AIRSEAL CAP ON THE TROCAR, IT BROKE APART." THE CUSTOMER REPORTED BEING ABLE TO RETRIEVE "A PORTION OF IT" AND REMOVED THE REMAINING RAYTEC "UNDER DIRECT VISUALIZATION WITH THE ROBOTIC SCOPE" USING A 5MM ATRAUMATIC LAPAROSCOPIC GRASPER. THE CUSTOMER CONFIRMED THAT ALL PIECES OF THE RAYTEC WERE ABLE TO BE REMOVED FROM THE BODY CAVITY.
Patient problems: Foreign Body In Patient
MAUDE report 23918599 ↗
Other laparoscopy kit devices
- Medline Industries, Inc. DYNJ82871Medline Industries, Inc. · laparoscopy kit5 recalls0 reports
- Medline Industries, Inc. CDS860015WMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. CDS860016RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ0426069NMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ905071FMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ52656BMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ21927RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ58561DMedline Industries, Inc. · laparoscopy kit3 recalls1 report
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
- 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