B. Braun Medical 500mL Sodium Chloride Irrigation Recall: Particulate Matter Hazard
B. Braun Medical recalls 500mL isotonic saline containers with particulate matter risk. Affected lots: J4K936 (exp 7/31/2027). Contact for return instructions.
Lower-risk recall
Presence of Particulate Matter
Contact the company
What happened, in plain English
B. Braun Medical is recalling 500mL plastic irrigation containers of 0.9% sodium chloride solution due to potential particulate matter. This could cause blockages or infections if used in medical procedures. Read more at govinfonow.com/recall/32166-b-braun-medical-500ml-sodium-chloride-irrigation-recall-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/32166-b-braun-medical-500ml-sodium-chloride-irrigation-recall-particulate-matter · Updated August 17, 2026 · FDA enforcement record: FDA #D-0353-2025
Cite this page
“B. Braun Medical 500mL Sodium Chloride Irrigation Recall: Particulate Matter Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32166-b-braun-medical-500ml-sodium-chloride-irrigation-recall-particulate-matter. Based on FDA recall #D-0353-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2025%22&limit=1).
Why it’s dangerous
Particulate matter in the solution could clog medical equipment or cause infections during irrigation procedures. This is a potential risk in clinical settings but not a direct health hazard for most users.
Who’s affected
Healthcare providers and patients using this saline solution for medical irrigation. Those with specific medical conditions requiring precise fluid administration may be at higher risk.
How to tell if you have this one
Check for the 500mL plastic irrigation container with lot number J4K936 (expires 7/31/2027). The product is labeled as 0.9% Sodium chloride Irrigation USP.
- Brand
B. Braun Medical- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number on the container; affected units have lot J4K936 expiring 7/31/2027.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to 12 distributors who may have further distributed the product nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0353-2025 (March 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0353-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.