DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-21 · Class II · Z-2995-2026
EventRecall classified
Effective2026-08-21
ClassificationClass II
On 2026-08-21 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU…. Recall Z-2995-2026. The firm initiated it on 2026-07-08. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2995-2026
- Classification
- Class II
- Classified on
- 2026-08-21
- Initiated on
- 2026-07-08
- Firm
- Medline Industries, LP
- Reason
- Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Product
- Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
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-2995-2026- 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
18535438d86a4a3861c8040f31efc6787122d0ce2018a14cf96aa9ff9d90e6df- 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)