Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: lack-of-sterilization
infection-risk
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 →

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

See all →

High
HealthLink Biopsy Punches Recalled for Lack of Sterilization
FDA (Devices) · 2013-07-10
High
HealthLink Biopsy Punches Recalled for Lack of Sterilization
FDA (Devices) · 2013-07-10

Same hazard · lack of sterilization