Medline brand medical procedure convenience kits — Class II medical device recall Z-0165-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0165-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 1,048 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10193489424850, 10193489469288, 10193489474589, 10193489650013, 10193489688993, 10193489807844, 10195327427849, 10195327444211, 10888277055308, 10888277226432, 10889942790371, 40193489424851, 40193489469289, 40193489474580, 40193489650014, 40193489688994, 40193489807845, 40195327427840, 40195327444212, 40888277055309, 40888277226433, 40889942790372 |
| Lot numbers | 23KBF265, 23LBK468, 23LBL117, 23LBN303, 23LBN742, 23LBO013, 23LBP975, 23LBS052, 23LBU414, 24ABC304, 24ABC805, 24ABD094, 24ABF270 |
| Model numbers | DYNJ42735A, DYNJ43457, DYNJ46717A, DYNJ53205B, DYNJ57895, DYNJ62803, DYNJ64376, DYNJ66619A, DYNJ68030, DYNJ68062, DYNJ84997 |
Product
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTOM PLASTIC PACK, REF DYNJ68062; m) PLASTIC LIMB SJHC-LF, REF DYNJ84997
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0165-2025. 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.