CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

BD Cathena Safety IV Catheter BD Multiguard Technology recalled

Becton Dickinson Infusion Therapy Systems is recalling BD Cathena Safety IV Catheter BD Multiguard Technology, distributed nationwide in the US. The recall was initiated on 21 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027

Quantity recalled262,800

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1808-2025
FDA event ID: 96696
Recalling firm: Becton Dickinson Infusion Therapy Systems, Sandy, UT
Classification: Class II
Status: Ongoing
Recall initiated: 21 Apr 2025
FDA classified: 21 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

21 Apr 2025	Recall initiated by company
21 May 2025	Classified by FDA	+30 days
28 May 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862

Where it was distributed

Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.

Nationwide Alabama Arizona California Florida Georgia Kansas Louisiana Massachusetts Maryland Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York Ohio Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027

Where was it sold?

Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Becton Dickinson Infusion Therapy Systems

All 15

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	REF: 382633, BD Insyte Autoguard BC Winged recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA recalled	Becton Dickinson Infusion Therapy Systems	Device Malfunction	Nationwide

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide