CLASS II Device recall · Reported 31 Jan 2018 · FDA Enforcement Report

Bd Max" CT/gc/tv recalled by Becton Dickinson &

Becton Dickinson & is recalling Bd Max" CT/gc/tv. The recall was initiated on 18 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.

Quantity recalledN/A

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-0394-2018
FDA event ID: 78808
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2017
FDA classified: 19 Jan 2018
Reported: 31 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

18 Jul 2017	Recall initiated by company
19 Jan 2018	Classified by FDA	+185 days
31 Jan 2018	Published in enforcement report	+12 days

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

Reason for recall

BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.

Where it was distributed

US and OUS.

Questions about this recall

Is Bd Max" CT/gc/tv recalled?

Yes. Becton Dickinson & recalled Bd Max" CT/gc/tv on 18 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0394-2018.

Why was it recalled?

Which lots are affected?

UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.

Where was it sold?

US and OUS.

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 21 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 &

All 361

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson &	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson &	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson &	Becton Dickinson &	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson &	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled	Becton Dickinson &	Processing Deviation	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide