Illumination packs recalled because packaging tape contains undisclosed latex
Stryker is recalling 39,148 NICO Myriad Illumination Packs because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: undisclosed latex in a product labelled latex-free can trigger an allergic reaction, and no injuries are reported.
Plain-English summary
The NICO Myriad Illumination Pack is being recalled, covering product number NN-1000 (11g illumination sleeve and fiber) and NN-1001 (13g illumination sleeve and fiber).
Tape used to secure components within the packaging contains latex, despite the products being labelled as latex-free. Stryker states latex could potentially cause an allergic reaction.
The recall covers 39,148 units, including GTIN 00816744021009 for NN-1000, across lots including 37AC5163, 37AE9811, 37AJ1438, 37BJ0513 and 37CB3410. Distribution was worldwide, including nationwide in the United States and to Australia, Belgium, Canada, England, Ireland and Italy. The FDA has classified the action as Class II.
A latex-free label is exactly what a latex-allergic patient or clinician relies on. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Stryker's instructions.
The recalled product
- Product
- NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
- Manufacturer
- Stryker Corporation
- Affected units
- 39,148
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by 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.
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