FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
- Recall number
- Z-0858-05
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
- Status
- Terminated
- Initiated
- 2005-05-05
- Posted
- 2005-06-01
- Terminated
- 2012-05-08
- Reason
- Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
- Root cause
- Other
- Action
- Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005.
- Quantity
- 159 cases (400 per case) =63,600 each.
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number: K621494
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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