Who should I contact about this recall?

Contact Becton Dickinson Infusion Therapy Systems, Inc. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

FDA Class II Recall: REF: 382633, BD Insyte Autoguard BC Winged, Shielded… by Becton Dickinson Infusion Therapy Systems, Inc.

Key facts

Recalling firm	Becton Dickinson Infusion Therapy Systems, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Classification	Class II
Recall number	Z-2000-2025
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

The short version: FDA classified a recall by Becton Dickinson Infusion Therapy Systems, Inc. as Class II, reported 20250702. The affected product is REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly (recall number Z-2000-2025). Reason for recall: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.. Status: Ongoing. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Becton Dickinson Infusion Therapy Systems, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Becton Dickinson Infusion Therapy Systems, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Becton Dickinson Infusion Therapy Systems, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Becton Dickinson Infusion Therapy Systems, Inc.’s FDA history

Argus HQ has recorded 13 total FDA actions tied to Becton Dickinson Infusion Therapy Systems, Inc.: 0 warning letters, 13 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Becton Dickinson Infusion Therapy Systems, Inc.'s recall?: FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Why was REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Cath recalled?: FDA's recall record states the reason as: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Who should I contact about this recall?: Contact Becton Dickinson Infusion Therapy Systems, Inc. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
Has Becton Dickinson Infusion Therapy Systems, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 13 total FDA actions tied to Becton Dickinson Infusion Therapy Systems, Inc., including 13 recalls and 0 warning letters.

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Full FDA history for Becton Dickinson Infusion Therapy Systems, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). FDA Class II Recall: REF: 382633, BD Insyte Autoguard BC Winged, Shielded… by Becton Dickinson Infusion Therapy Systems, Inc. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/becton-dickinson-infusion-therapy-systems-z-2000-2025-2025-07-02

MLA

"FDA Class II Recall: REF: 382633, BD Insyte Autoguard BC Winged, Shielded… by Becton Dickinson Infusion Therapy Systems, Inc. — Recall Details." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/recall/becton-dickinson-infusion-therapy-systems-z-2000-2025-2025-07-02.

Chicago

Argus HQ Research. "FDA Class II Recall: REF: 382633, BD Insyte Autoguard BC Winged, Shielded… by Becton Dickinson Infusion Therapy Systems, Inc. — Recall Details." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/becton-dickinson-infusion-therapy-systems-z-2000-2025-2025-07-02.

BibTeX

@misc{argushq_argushq_ai_recall_becton_dickinson_infusion_therapy_systems_z_2000_2025_2025_07_02_2025,
  title = {FDA Class II Recall: REF: 382633, BD Insyte Autoguard BC Winged, Shielded… by Becton Dickinson Infusion Therapy Systems, Inc. — Recall Details},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/becton-dickinson-infusion-therapy-systems-z-2000-2025-2025-07-02},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov — Recalls ↗