Medline Convenience kits used for various procedures: 1) PERI GYN PACK — Class II medical device recall Z-1615-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1615-2025 |
|---|---|
| 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 | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 671 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195327039899, 10195327079451, 10195327107758, 10195327128937, 10195327468804, 10195327694876, 10889942599394, 40195327039890, 40195327079452, 40195327107759, 40195327128938, 40195327468805, 40195327694877, 40889942599395 |
| Lot numbers | 24IBH305, 24JBN378, 24JBT902, 24JBU465, 24JBV636, 24KBB818, 24KBC171, 24KBC614 |
| Model numbers | DYNJ21824R, DYNJ21937J, DYNJ41949B, DYNJ51956B, DYNJ56417C, DYNJ67708A, DYNJ80786 |
Product
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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-1615-2025. 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.