FDA Device recall Z-0178-2027
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D by Medline Industries, citing medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking duri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-02 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Reason
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Identifiers
| code_info | UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Medline Industries
- Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC
FDA Device · Class II · 2026-10-21 · Medline Industries - Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J
FDA Device · Class II · 2026-10-21 · Medline Industries - Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &
FDA Device · Class II · 2026-10-21 · Medline Industries
All Medline Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.