FDA Device recall Z-2508-2026
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097
- FDA Device
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097 by Medline Industries, citing during an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2508-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-04 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
Reason
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Identifiers
| code_info | Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline…Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBF166; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23DBM780; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22KBM832; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22JBY524; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22GBR089; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBR153; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBC633; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22E |
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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-2508-2026%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.