- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21EBA066; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21CBW872; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBV936; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBL135; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBH924; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBT133; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBD523; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23ABM749; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 22JBH775; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24EDB118; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24DDC044; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB774; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB944; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA835; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA564; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 23KDB417; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21KDB767; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21IDC416; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB595; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB653; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 22DDA063; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23JBQ990; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23GBS121; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22HBB007; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22FBC016; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22BBE079; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22ABJ835; Medline Ki
- Units affected
- 168968 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2487-2026
- Recall initiated
- May 4, 2026
- FDA classification date
- June 17, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98994
- Last updated on HTM Vibe
- July 23, 2026