Medline 14 Fr Suction Catheter Kits recallZ-1312-2026 · Medline Industries, LP · initiated Dec 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA root cause category: Under Investigation by firm
What the company is doing
On December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply.
Recall details
- Recall number
- Z-1312-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 24, 2025
- Posted by the FDA
- Feb 6, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 141,971
- Product code
- OFR
- Distribution
- Distribution US nationwide and Canada.
Product description
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Code information (models, lots, serial numbers)
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYND40972Medline Industries, Inc. · Tracheobronchial suction catheter kit1 recall3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98285).
- Z-1313-2026 · Open, ClassifiedIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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