Class 2 Device Recall STRYKER

• Date Initiated by Firm: June 08, 2026
• Date Posted: August 03, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2863-2026
• Recall Event ID: 99340
• 510(K)Number: K042454
• Product Classification: Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
• Product: STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
• Code Information: GTIN 07613327061659, Batch Numbers: 24263FG2, 24264FG2, 24265FG2, 24267FG2, 24269FG2, 24270FG2, 24271FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24296FG2, 24297FG2, 24298FG2, 24304FG2, 24306FG2, 24313FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24327FG2, 24340FG2, 24341FG2, 24342FG2, 24343FG2, 24344FG2, 24345FG2, 24347FG2, 24348FG2, 24356FG2, 24357FG2, 24358FG2, 24361FG2, 25007FG2, 25010FG2, 25011FG2, 25015FG2, 25016FG2, 25017FG2, 25020FG2, 25021FG2, 25022FG2, 25023FG2, 25024FG2, 25027FG2, 25028FG2, 25030FG2, 25037FG2, 25038FG2, 25041FG2, 25042FG2, 25043FG2, 25049FG2, 25050FG2, 25051FG2, 25055FG2, 25065FG2, 25066FG2, 25069FG2, 25070FG2, 25071FG2, 25072FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25083FG2, 25084FG2, 25085FG2, 25086FG2, 25090FG2, 25091FG2, 25092FG2, 25093FG2, 25097FG2, 25098FG2, 25098GF2, 25099FG2, 25100FG2, 25104FG2, 25105FG2, 25106FG2, 25111FG2, 25112FG2, 25127FG2, 25128FG2, 25129FG2, 25132FG2, 25133FG2, 25134FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25143FG2, 25147FG2, 25148FG2, 25149FG2, 25150FG2, 25151FG2, 25153FG2, 25154FG2, 25155FG2, 25156FG2, 25157FG2.
• FEI Number: 2936485
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Ashley Cupples; 408-754-2000
• Manufacturer Reason for Recall: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued an URGENT: Medical Device Recall notice to its consignees on 7/6/2026 via USPS Certified Mail. The notice explained the issue, potential risks, and requested the following: "Actions needed: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product using Attachment B. 3. If affected product is found a. Quarantine, stop use and initiate the return process for affected units. b. Please complete Business Reply Form or use QR Code on Attachment A. 4. If affected product is NOT found: a. Please complete Business Reply Form or use QR Code on Attachment A. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility." For any additional information or questions please contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.
• Quantity in Commerce: 41,052 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = GCX