FDA recall, , Moderate risk
Medline Sterile Radiology Procedure Kits
Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, is recalling Sterile Radiology Procedure Kits, Model Number DYNDH1491B, because there is a potential breach in the sterile pouch packaging for one lot of the kits, which may compromise product sterility. The FDA added the recall to its Enforcement Report on March 27, 2026, and the company began the recall on February 18, 2026.
The recall involves 420 units distributed in Minnesota.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Sterile Radiology Procedure Kits
- Model number
- DYNDH1491B
- UDI-DI
- 40198459071455
- 10198459071454
- Lot code
- 25GBB924
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Minnesota.
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98529
- Recall number
- Z-1693-2026
- Quantity recalled
- 420 units
All recalls from Medline Industries, LP
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
