Recall Z-2999-2026 ยท OFR Tracheobronchial Suction Catheter Kit
Medline Industries, LP
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
| Date | Aug 21, 2026 (initiated Jul 10, 2026) |
| Status | Open, Classified |
| Reason | Component labeling discrepancy |
| Root cause | Labeling Change Control |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE CORRECTION notice to its sole consignee on 7/10/2026 via USPS and email. The notice explained the issue, potential risk, and attached the notice from Medtronic. The notice from Medtronic provided the following information: "Customer Actions: " Customers can continue to use the Covidien Shiley" disposable decannulation plugs. " Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue. " Share this notice with all relevant personnel within your organization, and with any orga |
| Quantity | 45 kits |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.