FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- Recall number
- Z-1312-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
- Status
- Open, Classified
- Initiated
- 2025-12-24
- Posted
- 2026-02-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 141,971
- Distribution
- Distribution US nationwide and Canada.
- Lot, serial or model codes
- Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFR
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28