DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-26 · Class II · Z-3025-2026
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) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q…. Recall Z-3025-2026. The firm initiated it on 2026-07-10. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3025-2026
- 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) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.
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-3025-2026- 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
f770ae3facfa1d3bbe753c14e982a9d352a97845a940da971d0e4152cc2418f1- 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)