MEDLINE NON-STERILE PVP SOLUTION — Class II medical device recall Z-2136-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-07-19, distributed nationwide. Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP
| Recall number | Z-2136-2023 |
|---|---|
| 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 | 2023-05-18 |
| Classified | 2023-07-12 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA |
| Quantity | 1,500 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10195327112554, 40195327112555, 40195327267149 |
| Lot numbers | 23BBE528, 23CBI693, 23DBC239, 23EBA381, 23FBA458 |
| Model numbers | DYNJ64572A, VAL050EEPKB |
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Reason for recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
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-2136-2023. 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.