Z-3126-2026Class I

Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

Name: Z-3126-2026 Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Creator: Medline Industries, LP
Published: 2026-08-11
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-08-11 / Open, Classified

FDA source

Recall record

Recall number: Z-3126-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-11
Posted: 2026-09-14
Recalling firm: Medline Industries, LP
Product: Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Product code: MCY Wound Dressing Kit
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.
FDA root cause: Nonconforming Material/Component
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 [email protected].
Quantity in commerce: 1100 kits
Distribution: US Nationwide distribution.
Product codes and lots: 1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3126-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3121-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3122-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3123-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3124-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3125-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3126-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14
Z-3127-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14

Product code MCY

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 2026-09-23. View this recall on fda.gov (opens on fda.gov)