MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81 — Class II medical device recall Z-0648-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-11, distributed nationwide. Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil wh
| Recall number | Z-0648-2025 |
|---|---|
| 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 | 2024-10-09 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,921 units |
| UPC / GTIN / UDI-DI | 10193489355284, 10193489958065, 10195327089368, 10195327167257, 10195327260019, 10195327270414, 10195327309541, 10195327350314, 10195327353063, 10195327369064, 10195327460648, 10195327515898, 40193489355285, 40193489958066, 40195327089369, 40195327167258, 40195327260010, 40195327270415, 40195327309542, 40195327350315, 40195327353064, 40195327369065, 40195327460649, 40195327515899 |
| Lot numbers | 22EBC473, 22EBR487, 22FBS940, 22FBX412, 22FDA445, 22FME241, 22HDA810, 22LDB968, 23CDB064, 23CMA495, 23CMB048, 23DBA280, 23FDA062, 23FDB836, 23FMG930, 23GMC980, 23GMD059, 23HDB222, 23IDB778, 23IME156, 23JDC086, 23KDB345, 23KMF753, 23KMH083, 23LME454, 24CBC467, 24CBM729, 24DDB815, 24FDB470, 24HME507, 24IME711 |
| Model numbers | DYNJ27466S, DYNJ41207C, DYNJ43147G, DYNJ63329D, DYNJ63329F, DYNJ64138B, DYNJ65808C, DYNJ81798A, DYNJ902256C, DYNJ909065, DYNJ909065A, DYNJVB91043A |
Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
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-0648-2025. 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.