Skip to content
Lower risk Medical device recall · FDA · Published December 15, 2020

Boston Scientific ACUITY 7060 Cutter Recall: Sterile Processing Issue

Boston Scientific recalls Model 7060 ACUITY cutters that may not have been properly sterilized, posing a risk of infection. Affected units were distributed in the US with specific GTIN and lot numbers.

🇺🇸 FDA recall #Z-0870-2021Medical deviceBoston Scientific ›
Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N Bldg 3 · Saint Paul, MN 55112-5700
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Model 7060 ACUITY Universal Cutters that did not undergo proper sterile processing. This could lead to infection risks if used on patients. Affected units have specific GTIN and lot numbers. Read more at govinfonow.com/recall/63663-boston-scientific-acuity-7060-cutter-recall-sterile-processing-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/63663-boston-scientific-acuity-7060-cutter-recall-sterile-processing-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0870-2021

Cite this page

“Boston Scientific ACUITY 7060 Cutter Recall: Sterile Processing Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63663-boston-scientific-acuity-7060-cutter-recall-sterile-processing-issue. Based on FDA recall #Z-0870-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0870-2021%22&limit=1).

The FDA announced on Dec. 15, 2020, that Boston Scientific Corporation is recalling five ACUITY Universal Cutter, Model 7060 units for failing to undergo applicable sterile processing procedures. The agency issued recall number Z-0870-2021.

How to tell if you have it

  • ACUITY Universal Cutter, MODEL 7060
  • UPC 08714729936176
  • Lot Number H1937249

The hazard

Boston Scientific is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure. The device is intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026), Boston Scientific LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026), and Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing (July 22, 2026). Other recent recalls of similar products include Boston Scientific Intracept Access Instruments Recall (April 22, 2026), American Contract Systems Medical Kits Recall (May 19, 2026), and Medline Convenience Kits Recall (Jan. 7, 2026).

How to tell if you have this one

Check for the model number 7060 on the ACUITY Universal Cutter. The GTIN is 08714729936176 and lot number H1937249 for affected units distributed in the US.

  • Brand
    Boston Scientific
  • Product
    ACUITY Universal Cutter, MODEL 7060
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number is 7060 and the GTIN is 08714729936176 with lot number H1937249.

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: “US Nationwide distribution including in the states of Tulsa, OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Dec 15, 202012. FDA classified it Class II: Jan 15, 202123. Published in FDA’s Enforcement Report: Jan 27, 202134. FDA terminated the recall: Aug 14, 2023420202023
  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.

Similar recalls

Latest medical device recalls

Keep exploring

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-0870-2021 (December 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0870-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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