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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune waste management system

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 Class 2 Device Recall Neptune waste management systemsee related information
Date Initiated by FirmMay 06, 2026
Date PostedJune 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2282-2026
Recall Event ID 98894
510(K)NumberK132671 
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
ProductNeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
Code Information GTIN 07613327634914, Serial Number 2521008873
FEI Number 3015967359
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactBrooke Thompson
269-800-1941
Manufacturer Reason
for Recall		It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStryker issued an URGENT Medical Device Field Action notice to its consignee on 5/6/2026 via FedEx. The notice explained the issue, potential risk and requested the consignee locate and quarantine the device. The consignee was directed to contact their Stryker Sales Rep to help schedule replacement of the affected device. For questions of concerns, contact Brooke Thompson at Instruments.Recalls@stryker.com.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of Indiana.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JCX
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