Agency classClass IIOur severity:Severe FDA (Drugs)·D-0497-2026·Announced 2026-04-29

Sodium Chloride for Irrigation Lacks Sterility Assurance

B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a sterile irrigation solution with confirmed defects (lack of sterility assurance and potential leakage). A compromised sterile product with loss of aseptic integrity poses risk of serious infection in medical irrigation applications. Class II recalls with risk of serious health consequences warrant Severe (4) classification.

Plain-English summary

B. Braun Medical Inc. is recalling 124,244 bags of 0.9% Sodium Chloride for Irrigation, USP, in 3000 mL bags (Rx only, NDC 0264-7388-60) distributed nationwide. The product lacks assurance of sterility and may leak from the diaphragm port once the foil is removed.

The affected lots are J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239 (expiration 30 April 2028), J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248 (expiration 30 April 2028), and J5H151, J5H152, J5H153, J5H154, J5H155 (expiration 31 May 2028). The product is manufactured by B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA.

Healthcare providers and patients who have received or are using this product should stop use immediately. For more information, contact the FDA or B. Braun Medical Inc.

The recalled product

Product: SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
Brand: SODIUM CHLORIDE FOR IRRIGATION
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Sterile Irrigation Solution
Hazard: lack-of-sterility
leakage
Affected units: 124,244

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)

Lot # J5E226
J5E227
J5E228
J5E229
J5E230
J5E231
J5E232
J5E233
J5E238
J5E239
Exp Date: 30Apr2028
Lot # J5E240
J5E241
J5E242
J5E243
J5E244
J5E245
J5E247
J5E248
Lot # J5H151

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same brand · SODIUM CHLORIDE FOR IRRIGATION

High
Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage
FDA (Drugs) · 2025-09-24

Same manufacturer · B BRAUN MEDICAL INC

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Same hazard · lack of sterility