CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report

BD BBL TB Stain Kit recalled by Becton Dickinson &

Becton Dickinson is recalling BD BBL TB Stain Kit K, distributed in 14 states. The recall was initiated on 12 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

Quantity recalled247 units

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-1296-2025
FDA event ID: 96244
Recalling firm: Becton Dickinson, Sparks, MD
Classification: Class II
Status: Ongoing
Recall initiated: 12 Feb 2025
FDA classified: 6 Mar 2025
Reported: 12 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Feb 2025	Recall initiated by company
6 Mar 2025	Classified by FDA	+22 days
12 Mar 2025	Published in enforcement report	+6 days

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

Reason for recall

One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

Product as listed by the FDA

BD BBL TB Stain Kit K, Catalog (REF): 212522

Where it was distributed

Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.

Arizona California Colorado Georgia Illinois Indiana Kentucky Massachusetts Maryland North Carolina New Jersey New York Texas Washington

Questions about this recall

Why was it recalled?

One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

Which lots are affected?

Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

Where was it sold?

Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.

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.

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