| | Class 2 Device Recall CURAD |  |
| Date Initiated by Firm | October 27, 2025 |
| Date Posted | December 11, 2025 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0898-2026 |
| Recall Event ID |
97978 |
| Product Classification |
Tape and bandage, adhesive - Product Code KGX
|
| Product | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F |
| Code Information |
UDI/DI 10888277702752 (each), 00888277702755 (box), 20888277702759 (case), ALL LOTS
|
| FEI Number |
1417592
|
Recalling Firm/ Manufacturer |
Medline Industries, LP 3 Lakes Dr Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay 866-359-1704 |
Manufacturer Reason for Recall | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. |
FDA Determined Cause 2 | Package design/selection |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/27/2025 via email and USPS first class mail. The notices explained the issue, potential risk, and requested the following:
"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-25-220
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."
For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
|
| Quantity in Commerce | 182,526 units |
| Distribution | US, Guam, Canada, United Arab Emirates |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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