High FDA (Devices)·Z-1654-2013·Announced 2013-07-10

HealthLink Biopsy Punches Recalled for Lack of Sterilization

Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterilization in a medical device, which poses a risk of harm (infection) even if specific injuries are not reported in the source text.

Plain-English summary

Clorox Healthcare Holdings, LLC (dba HealthLink) is recalling HealthLink Biopsy Punches, a disposable manual instrument used for skin biopsies. The recall is due to a lack of sterilization in the affected units.

The recall involves 1,044,600 units. These products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, Mexico, and New Zealand. The source text lists specific states and countries where the products were distributed.

Consumers and healthcare providers should stop using the affected biopsy punches and contact the manufacturer for further instructions. The source text does not specify a particular action beyond the recall itself, but standard procedure for medical device recalls involves discontinuing use and seeking guidance from the manufacturer or regulatory authorities.

The recalled product

Product: HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
Manufacturer: Clorox Healthcare Holdings, LLC (dba HealthLink)
Category: Medical Device — Surgical Instruments
Hazard: infection
lack-of-sterilization
Affected units: 1,044,600

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)

1232041
1232030
1232028
1232024
1232021
1232020
1232015
1232013
1232010
1232009
1231324
1231323
1226436
1226435 1226432
1226421
1226416
1226415
1226417
1226418
1226419

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
Severe
HealthLink Recalls Biopsy Punches Due to Lack of Sterilization
FDA (Devices) · 2013-07-10

Same hazard · infection