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Unrated Drug recall · FDA · Published September 5, 2017

Simple Diagnostics recalls Alcohol Prep Pads due to lack of sterility assurance

Simple Diagnostics recalls 100-count alcohol prep pads (70% isopropyl alcohol) that may not be sterile, posing infection risks. Affected lots expire 09/2019 or 12/2019.

🇺🇸 FDA recall #D-0134-2018DrugSimple Diagnostics ›
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Recalling firmSimple Diagnostics, Inc.11555 Heron Bay Blvd Ste 200 · Coral Springs, FL 33076-3362
✎ GovInfoNow plain-language explainer

What happened, in plain English

Simple Diagnostics is recalling 100 individual alcohol prep pads that may not be sterile. Using these pads could lead to infections during medical procedures or skin preparation. Read more at govinfonow.com/recall/41266-simple-diagnostics-recalls-alcohol-prep-pads-due-to-lack-of.

Source Summary by GovInfoNow · govinfonow.com/recall/41266-simple-diagnostics-recalls-alcohol-prep-pads-due-to-lack-of · Updated October 7, 2026 · FDA enforcement record: FDA #D-0134-2018

Cite this page

“Simple Diagnostics recalls Alcohol Prep Pads due to lack of sterility assurance.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41266-simple-diagnostics-recalls-alcohol-prep-pads-due-to-lack-of. Based on FDA recall #D-0134-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2018%22&limit=1).

Why it’s dangerous

The pads may not be sterile due to lack of assurance of sterility and cGMP deviations. This could lead to infections if used on broken skin or during medical procedures.

Who’s affected

Healthcare professionals and individuals using these pads for medical procedures or skin preparation. Those with open wounds or infections are at higher risk.

How to tell if you have this one

Check for the product name 'Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v)', 100 individual pads, and lot numbers SD2070420925 (exp. 09/2019), SD2070421201, or SD2070420601 (exp. 12/2019).

  • Brand
    Simple Diagnostics
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for lot numbers SD2070420925 (exp. 09/2019), SD2070421201, or SD2070420601 (exp. 12/2019) on the pads.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed throughout the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 5, 201712. FDA classified it Class II: Dec 26, 201723. Published in FDA’s Enforcement Report: Jan 3, 201834. FDA terminated the recall: Sep 19, 2018420172018
  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 #D-0134-2018 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0134-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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