| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 16, 2026 |
|---|
| Date Posted | April 01, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1706-2026 |
|---|
| Recall Event ID |
98530 |
| Product Classification |
Tracheobronchial suction catheter kit - Product Code OFR
|
| Product | Medline convenience kits containing Olympus biopsy valves:
1. BRONCH PACK, DYKE2096
2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182
3. PULMONARY BRONCH PACK, DYNDA2861A |
|---|
| Code Information |
1. UDI-DI
10198459629334 (EA)
40198459629335 (CS)
LOTS
26AMG895
2. UDI-DI
10198459545283 (EA)
40198459545284 (CS)
LOTS
25LBJ366
26ABR365
3. UDI-DI
10195327471859 (EA)
40195327471850 (CS)
LOTS
24EBA317
24EBV431
24IBD694
24JBQ783
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
800-633-5463 |
|---|
Manufacturer Reason
for Recall | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Firm notified customers on 2/16/26. Consignees were provided with a copy of Olympus's notification, which includes reminders to follow the IFU. According to the firm, the component can continue to be utilized by the customer, along with the remainder of the kit. |
|---|
| Quantity in Commerce | 14,379 kits total |
|---|
| Distribution | US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. |
|---|
| 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.
|
|
|
|
