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[Recalled] REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly — Due to customer complaints, there is the possibility that catheter needle may b… | FDA 2025-05-21

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Brand / manufacturerBecton Dickinson Infusion Therapy Systems, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2002-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date21 May 2025
EAN / barcode382903814336

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Becton Dickinson Infusion Therapy Systems, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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