Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules
Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving medical devices with potential for serious injury or hospitalization are categorized as Severe (Score 4).
Plain-English summary
Smiths Medical ASD, Inc. is recalling 3,980 units of Portex Spinal Anaesthesia Trays. The recall involves specific lots (2445604, 2440523, 2445605, 2445606, 2450812) of the Portex Spinal Tray with Drugs 25g Whitacre (catalog number 15597-20). These sterile, single-use devices are designed for regional anesthesia procedures, including spinal and epidural anesthesia.
The recall was initiated due to the presence of visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule (NDC # 0409-4712-01, Hospira Lot Number 23-227-DK). These specific ampules are included in the affected spinal trays. The FDA has classified this as a Class II recall.
The affected products were distributed nationwide, including in Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and Wyoming. Healthcare providers and facilities should stop using the affected trays and contact Smiths Medical ASD, Inc. for further instructions.
The recalled product
- Product
- Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar pu
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 3,980
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: 2445604
- 2440523
- 2445605
- 2445606
- 2450812
Distribution
Part of a larger recall action
This product is one of 9 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02