Z-2863-2026Class II

STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

Name: Z-2863-2026 STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Creator: Stryker Corporation
Published: 2026-06-08
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2026-06-08 / Open, Classified

FDA source

Stryker Corporation began a recall of STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 on 2026-06-08. FDA classified it as Class II and gives the reason as "There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2863-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-08-03
Recalling firm: Stryker Corp.
Product: STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA 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 [email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2863-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2862-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2863-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2864-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2865-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03
Z-2866-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code GCX

K042454Class IIStryker Cassette PumpStryker Endoscopy / cleared 2004-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)