The Recall Desk
ModerateFDA (Devices)·Z-2536-2017·Announced 2017-06-21

Cook Inc. Recalls Stamey Needles Due to Insufficient Reprocessing Instructions

Cook Inc. is recalling 698 Stamey Needles because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a documentation deficiency (insufficient reprocessing instructions) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity labeling/documentation issue.

Plain-English summary

Cook Inc. is recalling 698 units of the Stamey Needle. The recall was initiated because the reprocessing instructions provided with the devices do not offer sufficient detailed information for the cleaning, disinfection, and sterilization of the products.

The affected devices are identified by catalog numbers 095000, 095015, 095030, J-SYN-931600, J-SYN-931615, and J-SYN-931630. These devices were distributed nationwide within the United States and in several international locations, including Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, the Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

Healthcare facilities and users should stop using the affected Stamey Needles and contact Cook Inc. for further instructions regarding the recall.

The recalled product

Product
Stamey Needle
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
698

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 (6)

  • All lots Catalog numbers: 095000
  • 095015
  • 095030
  • J-SYN-931600
  • J-SYN-931615
  • J-SYN-931630

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · documentation deficiency

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