Medline Industries, Lp: Neurological Tray
Recall Summary Medline is recalling three medical procedure kits used in neurological procedures (Carotid Neuro Pack and VP Shunt CDS kits) because samples failed quality tests, showing problems with catheter surface finish, premature connector detachment, and incorrect catheter diameter. The kits were distributed worldwide, including throughout the United States and several other countries. This is a Class I recall, indicating a serious safety concern.
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9ce33a41-9ac1-4eb8-bafd-54fb32c3965f