The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1038-2016·Announced 2016-03-09

Stryker AccuPlace Round Level Needle Guide Recalled for Sterility Breach Risk

Stryker is recalling AccuPlace Round Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.

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, but the source text describes a 'potential' for sterility breach without reporting any actual illnesses, injuries, or hospitalizations, fitting the criteria for a voluntary precautionary recall or low-risk contamination.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the AccuPlace Round Level Needle Guide, a medical device used to assist users with inserting a needle at a predetermined angle for computer tomography. The recall involves 5,800 units of the device, specifically Model 0900-400-000 with lot numbers 61406002 and 61505003. These devices were distributed nationwide between May 1, 2013, and December 3, 2015, to locations in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.

The recall was initiated after an evaluation of the product packaging determined that there is a potential for the product to cause damage to the packaging. This damage could create a possible breach in sterility, which is a critical requirement for medical devices used in invasive procedures.

Healthcare facilities and consumers who have these specific devices should stop using them and contact Stryker for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
5,800

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 (2)

  • Stryker Model: 0900-400-000
  • With lot numbers: 61406002

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Stryker Instruments Div. of Stryker Corporation 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 4 products in this recall →

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