The Recall Desk
HighFDA (Devices)·Z-1596-2018·Announced 2018-05-09

Cook Inc. Recalls StoneBreaker Single Use Probes for Sterility Concerns

Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.

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, which indicates a risk of temporary or medically reversible adverse health consequences. The hazard involves potential lack of sterilization, which is a significant risk-of-harm product issue where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 12,556 units of the StoneBreaker Single Use Probe. The affected catalog numbers are SBP-010500, SBP-010605, SBP-016500, SBP-016605, and SBP-020425. The recall includes all lots of these products.

The recall was issued because the interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide in the United States and in 70 other countries, including Canada, the United Kingdom, Germany, and Australia. Healthcare providers and facilities should stop using these probes and contact Cook Inc. for further instructions.

The recalled product

Product
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
Manufacturer
Cook Inc.
Category
Medical Device — Urological Instrument
Hazard
Affected units
12,556

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Cook Inc. 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 7 products in this recall →

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