Medline DYND500MLSRecalls & reported problems
Medline Industries, Inc. · SOLUTION,SALINE,IRRGATION,500ML,STRL · Class U
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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389118405), received between Dec 4, 2023 and Sep 18, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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. 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
- Nov 6, 2023Class IOpen, Classified
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Z-0513-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Open or Remove Packaging Material3
- Delivered as Unsterile Product1
- Device Contamination with Chemical or Other Material1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Difficult to Open or Remove Packaging Material
It was reported that the sealant under the cap is very hard to remove and therefore is causing sterility concerns and issues with particles falling into the sterile liquid.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821588 ↗MalfunctionSep 9, 2026Unsealed Device Packaging
It was reported that "Ripped seal while opening. Would consider not sterile Adhesive and or seal over the lip of the bottle. We would not consider this not sterile. White adhesive residue on lip of bottle. Is that sterile?"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693428 ↗MalfunctionSep 7, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658024 ↗MalfunctionAug 28, 2026Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500908 ↗MalfunctionDec 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
ON 20-JAN-2023, CUSTOMER NOTIFIED NURSE ASSIST VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM CUSTOMER: RECEIVED 25 CASES OF BOTTLES OF DYND500MLS THAT WERE LEAKING. THERE WAS NO SHIPPING DAMAGE. THESE BOTTLES WERE REPORTED BY THE INITIAL REPORTER AS LEAKING PRIOR TO USE ON A PATIENT. THERE WAS NO REPORT OF ANY PATIENT IMAPCT OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255594 ↗
Other Dressing, wound, drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- SteriCare Solutions 6270Nurse Assist, Inc. · Dressing, Wound, Drug1 recall5 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.
How reports and recalls are matched · Editorial policy · Report an error on this page