Sterile Radiology Procedure Kits, Model Number DYNDH1491B
FDA Recall Z-1693-2026 · Posted 2026-03-27
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-02-18
Product Quantity420 units
Reason for Recall
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Firm Action
An URGENT MEDICAL DEVICE RECALL notification letter dated 2/18/26 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.
2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.
Website link: https://recalls.medline.com
Recall Reference #: R-26-015-FG
Recall Code:
3. Your account will receive credit once the response form is submitted.
4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form.
If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of MN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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