Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY — Class II medical device recall Z-1385-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-25, distributed nationwide. Medline has identified issues related to calibration of the equipment used to sterilize and package the device
| Recall number | Z-1385-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-01-07 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 753 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489478839, 10193489897890, 10195327534141, 40193489478830, 40193489897891, 40195327534142 |
| Lot numbers | 21ABK325, 21ABX057, 21CBH955, 21DBB713, 21FBA766, 21FBE305, 21FBS122, 21GBR275, 21GBR277, 21IBU128, 21JBJ227, 21WBA902, 22ABD970, 22ABM691, 22BBL555, 22BBM867, 22DBM224, 22DBR042, 22FBF305, 22FBX191, 22HBQ099, 22KBH787, 22LBK911, 23CBN841, 24ABR853 |
| Model numbers | DYKMBNDL55, DYKMBNDL55A, DYNJ85691 |
Product
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Reason for recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1385-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.