Agency classClass IIOur severity:Moderate FDA (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.

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 2/5 (Moderate).

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: documentation-deficiency
infection-risk
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 →

Same manufacturer · Cook Inc.

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Same hazard · documentation deficiency