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D-0296-2026 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA drug recall D-0296-2026 was initiated by Baxter Healthcare Corporation on December 22, 2025 and is designated Class II. Reason for recall: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution The recall status is ongoing. Affected quantity: 125,496 bottles.

Recall Details

Product Type
Drugs
Report Date
February 4, 2026
Initiation Date
December 22, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
125,496 bottles

Product Description

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Reason for Recall

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Distribution Pattern

Nationwide

Code Information

Lot #: G171359, expiry: 05/31/2027

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  • Z-2548-2026 Class I — Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog (May 21, 2026)
  • Z-2551-2026 Class I — Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Cat (May 21, 2026)
  • Z-2262-2026 Class II — Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog N (April 22, 2026)
  • Z-2638-2026 Class II — Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjun (April 21, 2026)
  • Z-1637-2026 Class I — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. (February 18, 2026)
  • Z-1573-2026 Class II — Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS (February 18, 2026)
  • Z-1368-2026 Class II — Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570 (January 13, 2026)
  • Z-1121-2026 Class II — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 (November 28, 2025)

FDA data resources