Z-2496-2026Class II

MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV...

Name: Z-2496-2026 MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV...
Creator: Medline Industries, LP
Published: 2026-05-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-04 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3)... on 2026-05-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2496-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-04
Posted: 2026-06-17
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
Product code: KDD Kit, Surgical Instrument, Disposable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 1432 units
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Product codes and lots: Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22HMA818; Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887, (each) 40195327191888, (case), Lot Number 22GMG188; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23FMB021; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23CMB395; Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764, (each) 40195327287765, (case), Lot Number 23BMF105; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 25BMG115; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG981; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KMG043; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24KME988; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24JMC883; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24HMG291; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMG957; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24GMC708; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD960; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMD976; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24CMC199; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMH271; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23LMC861; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMI184; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23JMC583; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23IMH859; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HME147; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23HMB823; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23GMD479; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FMH321; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 23FME722; Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119, (each) 40195327432110, (case), Lot Number 24EMC843; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26CME546; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 26AMD910; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25KMF065; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25IMI592; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017A; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25HMB017; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25GMK081; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25DMI874; Medline Kit Number/SKU DYNJ89414: UDI/DI 10198459272127, (each) 40198459272128, (case), Lot Number 25BME130; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 24CBE682; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBN771; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23LBJ194; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23KBO599; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23FBO284; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 23EBM695; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22IBP839; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22GBU984; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22EBB509; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22DBE259; Medline Kit Number/SKU DYNJ38052G: UDI/DI 10195327100131, (each) 40195327100132, (case), Lot Number 22CBX946; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 25CMI392; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 24LMA643; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 24EMD913; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23GMB073; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23FMF264; Medline Kit Number/SKU DYNJ47941F: UDI/DI 10195327381370, (each) 40195327381371, (case), Lot Number 23EMA833; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 24CMA172; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23LMB006; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23KMF820; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23FMA119; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 23AMG228; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 22HMB147; Medline Kit Number/SKU DYNJ38054G: UDI/DI 10195327100148, (each) 40195327100149, (case), Lot Number 22BMH157.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2496-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2479-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2480-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2481-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2482-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2483-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2484-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2485-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2486-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2487-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2488-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2489-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2490-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2491-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2492-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2493-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2494-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2495-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2496-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2497-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2498-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2499-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2500-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2501-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2502-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2503-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2504-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2505-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2506-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2507-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2508-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17

Product code KDD

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)