Smiths Medical ASD, Inc. Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot Number: K621494
Products Sold
Lot Number: K621494
Smiths Medical ASD, Inc. is recalling Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238 due to Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8". Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026