The Recall Desk
HighFDA (Drugs)·D-0652-2025·Announced 2025-09-24

[pending] STERILE WATER (WATER)

Pending LLM rewrite. Source: FDA_DRUG D-0652-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

The recalled product

Product
STERILE WATER (WATER)
Brand
STERILE WATER
Manufacturer
B BRAUN MEDICAL INC

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 (5)

  • Lot #: J3L519
  • J3L528
  • Exp.: 31AUG2026 Lot #: J4C522
  • J4C523
  • Exp.:28FEB2027

Distribution

Distributed nationwide across the United States.