FDAFDA · Food and drugs·Recall number Z-2491-2026

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

Published June 24, 2026 · Recall initiated: May 4, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: Medline Industries, LP
Distributor: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Lot: Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22FBM309; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22DBJ094; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22OBH091; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 21HBC428; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 24ABC426; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23JBM836; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23HBS357; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22KBS784; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22IBV574; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 26ABH211; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25GBS702; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25EBT418; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24LBP073; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24JBI868; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24HBW417; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24EBV861; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26CMK753; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMF647; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMB840; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25KMD227; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25JMB620; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25HME486; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25GMA169; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25EME427; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25CMG490; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25BMC915; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25AMD126; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMJ170; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMA267; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24IMH206; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMI841; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMA214; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24FMH462; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EMJ672; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EME216; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24DMK415; Medline Kit Number/SKU PHS41719A
Risk classification: Class II
Area (FDA): device
Country: United States

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