FDA Medical devices recall ·
BD BBL TB Stain Kit K recall
- Recall number
- Z-1296-2025
- Date
- (initiated February 12, 2025)
- Company / brand
- Becton Dickinson & Co.
7 Loveton Cir, Sparks, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 247 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD BBL TB Stain Kit K, Catalog (REF): 212522
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;
Distribution
Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.
States: Arizona California Colorado Georgia Illinois Indiana Kentucky Massachusetts Maryland North Carolina New Jersey New York Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1296-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.