The Recall Desk
SevereFDA (Devices)·Z-1656-2013·Announced 2013-07-10

HealthLink Recalls Biopsy Punches Due to Lack of Sterilization

Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterilization in a medical device used for invasive procedures, which poses a significant risk of infection or injury, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Clorox Healthcare Holdings, LLC (dba HealthLink) is recalling 772,600 units of Argent Surgical Systems Biopsy Punches. These are disposable manual instruments used for skin biopsies. The recall was initiated because the products were not sterilized.

The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, Mexico, and New Zealand. Specific states listed in the distribution pattern include Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, South Carolina, Texas, Virginia, Washington, Wisconsin, and Hawaii.

Consumers and healthcare facilities should stop using the recalled biopsy punches immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact the manufacturer or their supplier for further guidance.

The recalled product

Product
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Manufacturer
Clorox Healthcare Holdings, LLC (dba HealthLink)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
772,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1232040
  • 1232039
  • 1232038
  • 1232037
  • 1232029
  • 1232027
  • 1232026
  • 1232025
  • 1232023
  • 1232022
  • 1232019
  • 1232018
  • 1232017
  • 1232016
  • 1232014
  • 1232012
  • 1232011
  • 1232008
  • 1232007
  • 1232006

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Clorox Healthcare Holdings, LLC (dba HealthLink) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Clorox Healthcare Holdings, LLC (dba HealthLink)

See all →

Same hazard · lack of sterilization

See all →