See RES for full list — Class II medical device recall Z-2097-2026
Ongoing recall by Medline Industries, LP, reported 2026-05-13, distributed nationwide. Medline has identified issues related to calibration of the equipment used to sterilize and package the device
| Recall number | Z-2097-2026 |
|---|---|
| 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 | 2026-05-07 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 11,575 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489222777, 10193489238822, 10193489241860, 10193489391671, 10193489392197, 10193489416077, 10193489444179, 10193489448795, 10193489462708, 10193489478242, 10193489478334, 10193489478723, 10193489479393, 10193489490817, 10193489547184, 10193489584776, 10193489592047, 10193489877588, 10193489923926, 10193489951882, 10193489951912, 10193489952018, 10193489969351, 10193489976991, 10195327021085 and 145 more |
| Lot numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139 and 460 more |
| Model numbers | CDS983069G, CDS983069I, CDS983782C, DYKE1456D, DYKE1955, DYKMBNDL156, DYKMBNDL156A, DYKMBNDL156B |
Product
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
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-2097-2026. 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.