FDA Device recall Z-2995-2026
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545 by Medline Industries, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2995-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-08 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
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.
Identifiers
| code_info | Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396; Medline SKU Number…Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396; Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 26AMH848; Medline SKU Number DYNJ88056A, UDI 10198459372667 (each) 40198459372668 (case), Lot Number 25FMD894; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25JMH786; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF523; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF530; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 26CMD479; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABD437; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABO388; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Numb |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2995-2026%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.