The Recall Desk
HighFDA (Devices)·Z-1655-2013·Announced 2013-07-10

HealthLink Biopsy Punches Recalled for Lack of Sterilization

Clorox Healthcare Holdings is recalling 1,032,700 units of PSS Select Biopsy Punches because they were not sterilized. The products were distributed nationwide and in 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 FDA classified this as a Class II recall. The hazard is a lack of sterilization on a medical device, which presents a risk of harm (infection) but the source does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Clorox Healthcare Holdings, LLC (dba HealthLink) is recalling 1,032,700 units of PSS Select Biopsy Punches. These are disposable manual instruments used for skin biopsies. The recall is being conducted due to a lack of sterilization in the affected products.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico and specific states), as well as in Canada, Mexico, and New Zealand. The recall covers a wide range of product codes, including 1103316, 1100626, and 1100625, among many others listed in the official notice.

Consumers and healthcare providers should stop using these products immediately. The FDA has classified this as a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Manufacturer
Clorox Healthcare Holdings, LLC (dba HealthLink)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,032,700

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)

  • 1103316
  • 1100626
  • 1100625
  • 1100624
  • 1100623
  • 1100622
  • 1100621
  • 1100620
  • 1100619
  • 1100618
  • 1100617
  • 1100616
  • 1100615
  • 1100318
  • 1100317
  • 1100316
  • 1034725
  • 1034724
  • 1033414
  • 1031515

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)

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Same hazard · lack of sterilization

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