Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Recalled by Medisystems a NX Stage Company Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medisystems a NX Stage Company directly.
Affected Products
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Quantity: 26 casesx 250 needles (6500needles)
Why Was This Recalled?
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medisystems a NX Stage Company
Medisystems a NX Stage Company has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report