BD Recalls Epilor Syringes Due to Plunger Sticking Hazard
Becton Dickinson is recalling BD Epilor syringes because the plunger may stick, preventing users from detecting loss of resistance during epidural procedures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (failure to detect epidural space) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Company is recalling approximately 1,335,885 units of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe. The recall covers multiple catalog numbers and lots distributed worldwide, including the United States, Brazil, Australia, Canada, and Puerto Rico.
The recall was initiated after the company received reports that the syringe plunger may stall or stick within the device. This malfunction can prevent the user from detecting a loss of resistance when entering the epidural space, which is the primary purpose of the device.
Healthcare providers and facilities that have received these syringes should stop using them and contact Becton Dickinson for further instructions. The affected products are identified by specific catalog numbers and lot numbers listed in the official recall documentation.
The recalled product
- Product
- BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 1,335,885
Distribution
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