Reported Jun 24, 2026 · Ongoing
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc.…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- MEDLINE
- Medical Procedure Kits labeled asADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
- Lot codes and dates
295 of 295 products
Products covered by this recall Model / number Barcodes Product as published MNS121801065316032713440653160327135Medline Kit Number/ : UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22FBM309 MNS121801065316032713440653160327135Medline Kit Number/ : UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22DBJ094 MNS121801065316032713440653160327135Medline Kit Number/ : UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22OBH091 MNS121801065316032713440653160327135Medline Kit Number/ : UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 21HBC428 DYNJ67109B1019532720708340195327207084Medline Kit Number/ : UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 24ABC426 DYNJ67109B1019532720708340195327207084Medline Kit Number/ : UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23JBM836 DYNJ67109B1019532720708340195327207084Medline Kit Number/ : UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23HBS357 DYNJ67109B1019532720708340195327207084Medline Kit Number/ : UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22KBS784 DYNJ67109B1019532720708340195327207084Medline Kit Number/ : UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22IBV574 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 26ABH211 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25GBS702 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25EBT418 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24LBP073 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24JBI868 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24HBW417 DYNJ67109D1019532768910040195327689101Medline Kit Number/ : UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24EBV861 PHS41719A1019348978482440193489784825Medline Kit Number/ : UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26CMK753 PHS41719A1019348978482440193489784825Medline Kit Number/ : UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMF647 PHS41719A1019348978482440193489784825Medline Kit Number/ : UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMB840 PHS41719A1019348978482440193489784825Medline Kit Number/ : UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25KMD227 - Amount recalled
- 217390 units
This recall covers 64 products
The agency filed one notice per product. You are reading one of them; the other 63 are below.
51 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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