Class 2 Device Recall: Medline Heart Transplant Biopsy Kit (39 Units)

Class 2 Device Recall Medline Kits

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| | Class 2 Device Recall Medline Kits | |

3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley Barclay
866-359-1704 |
| Manufacturer Reason
for Recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| FDA Determined
Cause | No Marketing Application |
| Action | An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers.

REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product.
2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to
Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1
Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit.
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. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers.
Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com.

*** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers.

This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification.

REQUIRED ACTIONS:
same as for 2/25/26 letter |
| Quantity in Commerce | 39 units |
| Distribution | US Nationwide distribution. |
| Total Product Life Cycle | TPLC Device Report |

| 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. | |