Lifescan Inc One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
Brand
Lifescan Inc
Lot Codes / Batch Numbers
Lot SA4426, Part number 021-140-01
Products Sold
Lot SA4426; Part number 021-140-01
Lifescan Inc is recalling One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gent due to Lancet tip may not fully retract and cause needle stick and exposure to used lancets.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Recommended Action
Per FDA guidance
The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.
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