FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
- Recall number
- Z-0564-2013
- Recalling firm
- Becton Dickinson & Company
- Product
- Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
- Status
- Terminated
- Initiated
- 2012-10-02
- Posted
- 2012-12-19
- Terminated
- 2016-05-03
- Reason
- BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
- Root cause
- Mixed-up of materials/components
- Action
- Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
- Quantity
- 2,786,000 units
- Distribution
- (USA) nationwide
- Lot, serial or model codes
- Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419
- 510(k) numbers
- ["K980987"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28