Medtronic, Inc. Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Lot Number: 122596
Products Sold
Lot Number: 122596
Medtronic, Inc. is recalling Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH due to The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
Recommended Action
Per FDA guidance
Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, KY, LA, MT, NH, NY, PA, WI
Page updated: Jan 10, 2026