Arrow International Recalls Epidural Needles Due to Packaging Sterility Concerns
Arrow International is recalling 416,055 epidural needles because unsealed packaging may compromise product sterility. The recall covers distribution in the US and 35 other countries.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential sterility compromise due to packaging, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Epidural Needles, specifically product codes AN-05501 and AN-05505. The recall was initiated because product sterility may be compromised due to unsealed packaging.
The affected products were distributed nationwide in the United States and in 35 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers for both product codes are listed in the official recall documentation.
Healthcare providers and facilities should stop using the affected needles and contact Arrow International for instructions on return or replacement. Consumers are advised to check their medical records or consult their healthcare provider if they have received these specific products.
The recalled product
- Product
- Epidural Needle; Product Codes: AN-05501 and AN-05505
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International 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 76 products in this recall →Related recalls
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