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FDA Medical Device Recalls (openFDA)

Bd Medical Systems: BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.

Recall number
Z-0822-2011
Recalling firm
Bd Medical Systems
Product
BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.
Status
Terminated
Initiated
2010-06-24
Posted
2010-12-28
Terminated
2012-06-29
Reason
Blades may contain defects at the blade tip or cutting edge.
Root cause
Process control
Action
BD Medical notified customers via letter dated 6/24/10 to discontinue use of product and remove from inventory. Customers were instructed to complete the customer response form and fax to BD Medical. BD Medical was to contact customers upon receipt of the customer response form to arrange for replacement. Unused product was to be returned to: BD Medical Ophthalmic Systems Attn: WT-12582 411 Waverly Oaks Road Building 2, Suite 229 Watham, Massachusetts 02452-8402 For questions regarding this recall call 1-781-906-7952.
Quantity
524 pieces
Distribution
Nationwide Distribution
Lot, serial or model codes
Lot #9138996 Exp: 2014-05
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
Firm FEI
3004589032
Firm city
Waltham
Firm state
MA
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

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