Z-1312-2026Class II

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

Name: Z-1312-2026 Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Creator: Medline Industries, LP
Published: 2025-12-24
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-24 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit on 2025-12-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1312-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-24
Posted: 2026-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Product code: OFR Tracheobronchial Suction Catheter Kit
Reason for recall: 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: 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 in commerce: 141,971
Distribution: Distribution US nationwide and Canada.
Product codes and lots: Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1313-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code OFR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)