Boston Scientific Corporation Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
6503654, 6513396, 6544512
Products Sold
6503654, 6513396, 6544512
Boston Scientific Corporation is recalling Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, due to Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
Recommended Action
Per FDA guidance
Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.
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