FDA Medical Device Recalls (openFDA)
Southmedic, Inc.: Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
- Recall number
- Z-1892-2018
- Recalling firm
- Southmedic, Inc.
- Product
- Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
- Status
- Terminated
- Initiated
- 2017-11-06
- Posted
- not on file
- Terminated
- 2020-04-02
- Reason
- Scalpels lot contains non-sterile products labeled as sterile.
- Root cause
- Process control
- Action
- On November 6th, 2017 , Southmedic sent notification to all their customers stating that: Southmedic Inc. is conducting a voluntary recall of a specific lot number of the Southmedic Sterile Disposable Scalpel (73-0115) Lot#: 092517 due to an incorrect sterility status having been identified on the label. This may result in non-sterile products being labeled as sterile. After checking your inventory, please complete the attached Voluntary Recall Notification Confirmation Form and fax to (705) 728 9537. We apologize for any inconvenience this action may cause. Your immediate attention is appreciated. We apologize for any inconvenience this action may cause. Your immediate attention is appreciated. For product return questions please contact Customer Service at (800) 463- 7146 ext 307.
- Quantity
- 3,300 scalpels
- Distribution
- US Distribution to the states of : IA, IL, NE, NY and TX
- Lot, serial or model codes
- Part Number 73-0115 Lot Number 092517
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDX
- Firm FEI
- 3001717360
- Firm city
- Barrie
- Firm state
- not on file
- Firm country
- Canada
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