FDA Medical Device Recalls (openFDA)
Stryker Corporation: STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Recall number
- Z-2862-2026
- Recalling firm
- Stryker Corporation
- Product
- STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-08-03
- Terminated
- not on file
- Reason
- There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Root 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
- 46,212 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.
- Lot, serial or model codes
- GTIN 07613327061499, Batch Numbers: 24262FG2, 24263FG2, 24264FG2, 24266FG2, 24267FG2, 24268FG2, 24269FG2, 24283FG2, 24284FG2, 24286FG2, 24287FG2, 24288FG2, 24289FG2, 24290FG2, 24291FG2, 24292FG2, 24293FG2, 24294FG2, 24295FG2, 24296FG2, 24298FG2, 24299FG2, 24302FG2, 24303FG2, 24304FG2, 24305FG2, 24306FG2, 24309FG2, 24311FG2, 24312FG2, 24316FG2, 24317FG2, 24318FG2, 24319FG2, 24320FG2, 24321FG2, 24322FG2, 24323FG2, 24324FG2, 24325FG2, 24326FG2, 24337FG2, 24339FG2, 24346FG2, 24347FG2, 24348FG2, 24349FG2, 24350FG2, 24351FG2, 24352FG2, 24353FG2, 24354FG2, 24355FG2, 24356FG2, 24358FG2, 24361FG2, 25007FG2, 25008FG2, 25009FG2, 25010FG2, 25013FG2, 25014FG2, 25017FG2, 25020FG2, 25027FG2, 25028FG2, 25029FG2, 25035FG2, 25036FG2, 25037FG2, 25038FG2, 25041FG2, 25043FG2, 25044FG2, 25045FG2, 25048FG2, 25052FG2, 25055FG2, 25056FG2, 25057FG2, 25058FG2, 25059FG2, 25062FG2, 25063FG2, 25064FG2, 25065FG2, 25069FG2, 25070FG2, 25071FG2, 25073FG2, 25076FG2, 25077FG2, 25078FG2, 25079FG2, 25080FG2, 25084FG2, 25085FG2, 25086FG2, 25087FG2, 25092FG2, 25093FG2, 25094FG2, 25097FG2, 25098FG2, 25099FG2, 25100FG2, 25101FG2, 25107FG2, 25112FG2, 25113FG2, 25114FG2, 25115FG2, 25118FG2, 25119FG2, 25120FG2, 25121FG2, 25122FG2, 25125FG2, 25126FG2, 25134FG2, 25135FG2, 25137FG2, 25139FG2, 25140FG2, 25141FG2, 25142FG2, 25144FG2, 25148FG2, 25155FG2, 25160FG2, 25161FG2, 25162FG2, 25163FG2.
- 510(k) numbers
- ["K042454"]
- PMA numbers
- not on file
- Product code
- GCX
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28