The Recall Desk
Severity pendingFDA (Devices)·Z-0236-2026·Announced 2025-10-29

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packag

Pending LLM rewrite. Source: FDA_DEVICE Z-0236-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

The recalled product

Product
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrum
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Catalog Number: 44138509
  • UDI/DI: 00382904413859
  • Serial Numbers: FT5675
  • FT5497
  • FT4948
  • FT5781
  • FT5120
  • FT3993
  • FT7779
  • FT3387
  • FT1993
  • FT5019
  • FT9109
  • FT8412
  • FT7176
  • FT7344
  • FT4282
  • FT7400
  • FT6093
  • FT0962

Distribution

Distributed nationwide across the United States.

Related recalls

Same category