BD Syringe Tip Cap Packaging Defect May Compromise Sterility
Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.
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: FDA Class II medical device recall with no reported illnesses or injuries. The defect involves holes in packaging that compromise the integrity of a sterile product, creating a risk of sterility loss—fitting the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Becton Dickinson & Company is recalling BD Syringe Tip Cap Bulk Sterile Convenience Pak (Catalog Number 305822) because holes exist in the product packaging. These holes compromise package integrity and may compromise the sterility of the product. The syringe tip caps are used to seal syringes and maintain container closure integrity.
The recalled lot includes Lot Number 1111347 with an expiration date of April 30, 2026. Approximately 8,000 units were distributed in Texas.
The recalled product
- Product
- BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 8,000
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 (1)
- Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225
Distribution
Distributed in 1 state:
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