DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-26 · Class II · Z-3020-2026
EventRecall classified
Effective2026-08-26
ClassificationClass II
On 2026-08-26 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P…. Recall Z-3020-2026. The firm initiated it on 2026-07-10. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3020-2026
- Classification
- Class II
- Classified on
- 2026-08-26
- Initiated on
- 2026-07-10
- Firm
- Medline Industries, LP
- Reason
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Product
- Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3020-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
f991427ead32d0d3777431e9ec7cfe03762c9395446fa59bdbe0170890b4b2b0- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)