FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
- Recall number
- Z-0588-2021
- Recalling firm
- Becton Dickinson & Company
- Product
- BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
- Status
- Terminated
- Initiated
- 2020-11-18
- Posted
- not on file
- Terminated
- 2024-02-15
- Reason
- BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
- Root cause
- Under Investigation by firm
- Action
- Customers are provided with the following actions to take in the firm's recall notification letter: 1. Immediately review your inventory for the specific Catalog (Ref) and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Replacements will be provided for all discarded inventory. If you require further assistance, please contact: BD Contact: Customer/Technical Support US Contact Information: (844) 823-5433 MonFri 8:30am and 5:00pm (EST) Areas of Support: For customers outside the US, contact your local BD representative or distributor
- Quantity
- 1,430,000
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore.
- Lot, serial or model codes
- Catalog Ref No.: 305106 Lot No:. 9128897 Expiration Date: 2024-06-30 UDI: 30382903051060 Product Package Size: 100 units per carton
- 510(k) numbers
- ["K021475"]
- PMA numbers
- not on file
- Product code
- FMI
- 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