FDA Medical Device Recalls (openFDA)
Miltex, Inc.: Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.
- Recall number
- Z-0767-2007
- Recalling firm
- Miltex, Inc.
- Product
- Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.
- Status
- Terminated
- Initiated
- 2007-04-09
- Posted
- 2007-04-21
- Terminated
- 2007-08-07
- Reason
- Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)
- Root cause
- Other
- Action
- The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall.
- Quantity
- 400 boxes
- Distribution
- Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA.
- Lot, serial or model codes
- Part number 4-422, Lot number S07A10
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GES
- Firm FEI
- 2518040
- Firm city
- York
- Firm state
- PA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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