Medline Convenience Kits: 1) CVC PACK — Class II medical device recall Z-2102-2026
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-2102-2026 |
|---|---|
| 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 | 1,516 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160327649, 00653160352733, 00653160354881, 00653160360424, 00653160360790, 10193489111002, 10193489111019, 10193489111330, 10193489112368, 10193489190236, 10193489190250, 10193489190311, 10193489191219, 10193489191257, 10193489199901, 10195327058715, 10653160327646, 10653160352730, 10653160354888, 10653160360421, 10653160360797, 10888277733794, 20193489111009, 20193489111016, 20193489111337 and 9 more |
| Lot numbers | 2020121550, 2023050490, 2023060290, 2023063090, 2023070590, 2023071290, 2023072590, 2023080190, 2023081490, 2023101680, 2023102790, 2023111590, 2023112780, 2023120590, 2023120890, 2023121190, 2023121490, 2024010880, 2024011790, 2024012490, 2024012590, 2024022190, 2024030690, 2024031590, 2024032990, 2024040180, 2024041790, 2024052290, 2024053190, 2024060590, 2024061890, 2024062890, 2024071790, 2024071990, 2024072390, 2024080190, 2024091290, 2024092390, 2024093090, 2024100790 and 7 more |
| Model numbers | CVI4500A, DYKM1730A, DYKM1751A, DYKM1756A, DYKM1765A, DYKM1767B, DYKM1776, DYKM1781A, DYKM1783A, DYKM1796A, DYKM1801B, DYKM1807, DYKM1864, DYKM1925, DYKM1927A, DYKM1977B, DYKM2131 |
Product
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131
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-2102-2026. 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.