FDA Classifies Field Correction As Class I Recall Due to Risk of Serious Injury
The U.S. Food and Drug Administration (FDA) has classified a correction issued by Arrow International, a subsidiary of Teleflex, as a Class I recall after certain convenience kits were found to contain injectable medications previously recalled by manufacturer Huons Co., Ltd.
The correction affects various Arrow surgical kits and procedure sets that include:
- 0.9% sodium chloride (10 mL saline) ampules
- Lidocaine ampules
- Bupivacaine ampules
The recall does not involve removing the convenience kits themselves from hospitals or healthcare facilities. Instead, healthcare providers are instructed to discard the affected injectable medications before using the kits and obtain replacement medications through their facility pharmacy.
Why the correction was issued
The affected injectable products were manufactured by Huons Co., Ltd., which previously initiated a recall involving the saline, lidocaine, and bupivacaine ampules.
According to FDA, using compromised injectable medications could lead to infection, inflammatory reactions, and reduced or absent anesthetic effect.
If lidocaine or bupivacaine fails to provide adequate anesthesia, patients could experience inadequate pain control, surgical complications, emergency conversion to alternative procedures, repeat or delayed procedures, and patient distress.
As of April 20, 2026, Arrow reported no serious injuries and no deaths associated with this issue.
What healthcare facilities should do
Arrow recommends that healthcare providers do not use the saline, lidocaine, or bupivacaine ampules supplied in affected kits, discard the affected ampules immediately when opening the kit, obtain replacement saline and anesthetic medications through the facility pharmacy, and inform all affected clinical personnel of the correction.
The remaining components of the convenience kits may continue to be used as intended once the affected injectable products have been removed.
Why it matters
This correction demonstrates how a quality issue involving a single component can affect multiple downstream medical products.
Although the convenience kits themselves are not defective, the inclusion of previously recalled injectable medications required corrective action because patient safety depends on every component of a procedural kit performing as intended.
FDA classified the action as a Class I recall, its most serious recall category, because compromised injectable medications used during surgical procedures could result in serious patient harm.
Links
Read the FDA’s announcement here.
Pharmacal Recalls MG217 Eczema Cream
Pharmacal Recalls MG217 Eczema Cream Due to Staphylococcus aureus ContaminationFDA posts nationwide recall after microbial contamination found in topical skin treatment Pharmacal has voluntarily recalled one lot of MG217 Multi-Symptom Treatment Cream & Skin...
Cefazolin Injection Recalled Due to Cardboard in Sterile IV Solution
Baxter Recalls Cefazolin Injection Sterile IV SolutionCardboard Particulate Matter Found in a Sterile Intravenous Infusion Bag Baxter International has voluntarily recalled one lot of Cefazolin in Dextrose Injection, USP, 2 g/100 mL after a report of cardboard...
Editorial: Two Days Later, Another Moringa Recall
Recurring Moringa Recalls Highlight Ongoing Supply Chain Concerns On July 17, the U.S. Food and Drug Administration officially closed its investigation into a multistate Salmonella outbreak linked to MOGO-brand moringa capsules. The outbreak was not insignificant....
Moringa Capsules Recalled for Potential Salmonella Contamination
Zen Principle Recalls Moringa Capsules After FDA Detects Salmonella in Raw Ingredient Relay Peak Research LLC, doing business as Zen Principle Naturals, has voluntarily recalled one lot of its Zen Principle® Moringa Capsules after learning that the raw moringa leaf...
Eight Months of Moringa Salmonella Outbreaks
Recurring Salmonella Outbreaks Raise Questions About Supplement Oversight Since November 2025, the U.S. Food and Drug Administration has investigated and coordinated multiple recalls involving moringa dietary supplements contaminated with Salmonella. What initially...
FDA Closes Moringa Salmonella Outbreak Investigation
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have concluded their investigation into a multistate Salmonella Typhimurium outbreak linked to MOGO-brand moringa powder capsules distributed by MOGO Moringa LLC of St. Louis,...
