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Lower risk Medical device recall · FDA · Published November 6, 2017

Southmedic Sterile Scalpels Recall: Non-sterile Products Risk Infection

Southmedic recalls sterile disposable scalpels due to non-sterile products in some lots. This could lead to infection during medical procedures. Affected lots include 092517.

🇺🇸 FDA recall #Z-1892-2018Medical deviceSouthmedic ›
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Recalling firmSouthmedic, Inc.50 Alliance Blvd · Barrie, Canada
✎ GovInfoNow plain-language explainer

Southmedic is recalling sterile disposable scalpels because some lots contain non-sterile products. Using these could lead to infections during medical procedures. Affected items have lot number 092:2517. Read more at govinfonow.com/recall/72603-southmedic-sterile-scalpels-recall-non-sterile-products-risk-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/72603-southmedic-sterile-scalpels-recall-non-sterile-products-risk-infection · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1892-2018

Cite this page

“Southmedic Sterile Scalpels Recall: Non-sterile Products Risk Infection.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72603-southmedic-sterile-scalpels-recall-non-sterile-products-risk-infection. Based on FDA recall #Z-1892-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1892-2018%22&limit=1).

The FDA announced on 2017-11-06 that Southmedic, Inc. is recalling Southmedic Sterile Disposable Scalpels because lots contain non-sterile products labeled as sterile. The recall affects 3,300 units distributed to Iowa, Illinois, Nebraska, New York and Texas.

How to tell if you have it

  • Brand: Southmedic
  • Product: Southmedic Sterile Disposable Scalpel Rx only
  • Part Number: 73-0115
  • Lot Number: 092517

The hazard

The scalpels are intended for use in various medical procedures for preparation, scraping and/or cutting of tissue. The hazard is that the product lot contains non-sterile items labeled as sterile.

Context

GovInfoNow's records show Southmedic, Inc. has issued three other recalls since 2017-10-17, including a 2022-10-27 recall for non-sterile safety cartridges sold as sterile and a 2021-05-25 recall regarding oxygen tubing that may disconnect. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (2026-01-07), Medline Centurion Shave Kits Recall: Non-sterile Alcohol Prep Pads Risk Infection (2026-03-16) and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12).

How to tell if you have this one

Check the lot number on the packaging, which is 092517 for affected items. The product is labeled as 'Southmedic Sterile Disposable Scalpel Rx only'.

  • Brand
    Southmedic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for lot number 092517 on the packaging to identify affected items.

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US Distribution to the states of : IA, IL, NE, NY and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Iowa, Nebraska, New York, Texas.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Nov 6, 201712. FDA classified it Class II: May 17, 201823. Published in FDA’s Enforcement Report: May 23, 201834. FDA terminated the recall: Apr 2, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1892-2018 (November 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1892-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA