Z-1892-2018Class II

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures...

Name: Z-1892-2018 Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures...
Creator: Southmedic, Inc.
Published: 2017-11-06
License: https://open.fda.gov/license/

Southmedic Inc. / initiated 2017-11-06 / Terminated / root cause: manufacturing process

FDA source

Southmedic, Inc. began a recall of Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue on 2017-11-06. FDA classified it as Class II and gives the reason as "Scalpels lot contains non-sterile products labeled as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1892-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-06
Posted: 2018-05-17
Terminated: 2020-04-02
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.
Product code: GDX Scalpel, One-Piece
Reason for recall: Scalpels lot contains non-sterile products labeled as sterile.
Root cause tag: manufacturing process
FDA 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 in commerce: 3,300 scalpels
Distribution: US Distribution to the states of : IA, IL, NE, NY and TX
Product codes and lots: Part Number 73-0115 Lot Number 092517

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1892-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-17

Product code GDX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)