FDA Medical Device Recalls (openFDA)
Lifescan Inc: OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
- Recall number
- Z-2027-2010
- Recalling firm
- Lifescan Inc
- Product
- OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
- Status
- Terminated
- Initiated
- 2010-02-24
- Posted
- 2010-07-17
- Terminated
- 2010-12-08
- Reason
- Products may provide inaccurate results at readings over 400 mg/dL
- Root cause
- Other
- Action
- The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.
- Quantity
- 1,014,350
- Distribution
- Worldwide distribution: USA and countries of Europe, Latin America and Asia.
- Lot, serial or model codes
- Part Number 02005201 (100 count), lot numbers 2969798, 2969251, 2982369, 2983467; Part number 01035904 (50 count), lot numbers 2969795 and 2982566; Part number 02096401 (50 count mail order pack), lot numbers 2969481 and 2998193
- 510(k) numbers
- ["K022724"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- 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
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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