Stat Medical Devices, Inc. Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously.
Brand
Stat Medical Devices, Inc.
Lot Codes / Batch Numbers
Part # Lot # Exp Date PNS-100 SBSM-1107-1 11/2012 SBSM-0608-1 06/2013 and SBSM-1008-1 10/2013, 24-1010 (PNS-100) SBAL-1107-1 11/2012, 24-1215 (PNX-100) SBAL-1107-1 11/2012, and 24-1210 (PNM-100) SBAL-1107-1 11/2012.
Products Sold
Part # Lot # Exp Date PNS-100 SBSM-1107-1 11/2012 SBSM-0608-1 06/2013 and SBSM-1008-1 10/2013; PNX-100 SBSM-1107-1 11/2012 SBSM-0408-1 04/2013 SBSM-0508-1 05/2013 SBSM-0608-1 06/2013 SBSM-0908-1 09/2013 SBSM-1008-1 10/2013 and SBSM-1108-1 11/2013; PNM-100 SBSM-1107-1 11/2012 SBSM-0408-1 04/2013 SBSM-0508-1 05/2013 SBSM-0608-1 06/2013 SBSM-0908-1 09/2013 SBSM-1008-1 10/2013 and SBSM-1108-1 11/2013; 24-1010 (PNS-100) SBAL-1107-1 11/2012; 24-1215 (PNX-100) SBAL-1107-1 11/2012; and 24-1210 (PNM-100) SBAL-1107-1 11/2012.
Stat Medical Devices, Inc. is recalling Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silico due to Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.
Recommended Action
Per FDA guidance
An "Urgent: Medical Device Recall Notification" letter dated June 18, 2009 was issued to direct customers requesting return of affected product and requesting they send notification to any customers which may have received the affected product from them. Direct questions about the recall to Stat Medical Devices by calling 1-978-774-1469.
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 noticeDistribution
As reported by FDA
CO, PR
Page updated: Jan 10, 2026