Alcon Laboratories, Inc Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
Brand
Alcon Laboratories, Inc
Lot Codes / Batch Numbers
Lot #632178H, 634400H and 642229H.
Products Sold
Lot #632178H, 634400H and 642229H.
Alcon Laboratories, Inc is recalling Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); in due to Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
Recommended Action
Per FDA guidance
Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.
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
AR, IN, MN, NY, TX, WI
Page updated: Jan 10, 2026