Device recalls

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…

Open, ClassifiedNonconforming Material/ComponentZ-3125-2026
Open FDA's page for this record
Cfres ID
222142
Product res number
Z-3125-2026
Event date initiated
2026-08-11
Event date posted
2026-09-14
Recall status
Open, Classified
Res event number
99669
Product code
LRS
Product description
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Firm FEI number
1417592
Recalling firm
Medline Industries, LP
Address 1
3 Lakes Dr
City
Northfield
State
IL
Postal code
60093-2753
Additional info contact
Haley Barclay 866-359-1704
Root cause description
Nonconforming Material/Component
Product quantity
2718 kits
Distribution pattern
US Nationwide distribution.
Code info

1) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24GMD979; 2) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24FBM840; 3) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24HBK903

Reason for recall

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX3 Recall Code: 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Harmonized identifiers (openFDA)
Device name
I.V. Start Kit
Medical specialty description
General Hospital
Regulation number
880.5200
Device class
2
K number
K871731, K935684, K951167, K844614, K871281, K923361, K760876, K001879, K942238, K820490, K863712, K943941, K963722, K941469, K950184, K925017, K933041, K863796, K924538, K914475, K930196, K852375, K842898, K922533, K875315, K050654, K925018, K926031, K924811, K944041
Registration number
1060680, 3026197444, 2433012, 3006673317, 1422634, 9610847, 1423507, 3003911670, 3004519921, 3015416207, 3013764800, 3010220595, 3035365737, 1223004, 3014527916, 2244771, 1043214, 3004111573, 9616088, 3005669815, 1030451, 9680794, 1047429, 1423395, 1220477, 3024354784, 2029015, 3004122598, 3010131137, 1721432, 2245270, 1123010, 1423537, 3004468406, 1643817, 3015058854, 1710034, 3003674698, 3008258694, 3007329020 +30 more
FEI number
3026197444, 2433012, 3002902735, 3003911670, 3015416207, 3013764800, 3010220595, 3035365737, 1000514656, 3014527916, 2244771, 1043214, 3004111573, 1000208624, 3005669815, 1030451, 3000717925, 1047429, 1220477, 3024354784, 3004122598, 3010131137, 1721432, 2245270, 3005596530, 1000120555, 3011649541, 3004468406, 1000112968, 1643817, 1000123297, 3015058854, 1710034, 3003674698, 3008258694, 3007329020, 3014257280, 1928237, 3015173212, 3005595283 +30 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.