High FDA (Devices)·Z-2496-2026·Announced 2026-06-24

Medline cardiovascular draping and basin kits contain substandard catheters

Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.

Plain-English summary

Medline Industries, LP is recalling CV Draping/Basin medical procedure kits, covering SKUs DYNJ908483A, DYNJ908483B and DYNJ908483C among the products listed in the recall notice. The action covers 1,432 units.

During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.

The recalled product

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 DY
Manufacturer: Medline Industries, LP
Category: Medical Device — Surgical procedure kit
Hazard: out-of-specification
catheter-defect
connector-detachment
class-ii
Affected units: 1,432

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887
(each) 40195327191888
(case)
Lot Number 22HMA818
Lot Number 22GMG188
Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764
(each) 40195327287765
Lot Number 23FMB021
Lot Number 23CMB395
Lot Number 23BMF105
Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119
(each) 40195327432110
Lot Number 25BMG115
Lot Number 24KMG981
Lot Number 24KMG043
Lot Number 24KME988
Lot Number 24JMC883
Lot Number 24HMG291
Lot Number 24GMG957
Lot Number 24GMC708

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 30 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 30 products in this recall →

Same manufacturer · Medline Industries, LP

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