Z-2622-2010

Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium...

Name: Z-2622-2010 Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium...
Creator: Stryker Endoscopy
Published: 2010-06-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-06-21 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by... on 2010-06-21. The reason FDA records is "Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2622-2010
Status: Terminated
Initiated: 2010-06-21
Posted: 2010-09-29
Terminated: 2010-12-16
Recalling firm: Stryker Corp.
Product: Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.
Quantity in commerce: 191855 units
Distribution: Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
Product codes and lots: Model number 502-360-000, all serial numbers

Product code GCJ

K053311Class IIStryker Scope WarmerStryker Endoscopy / cleared 2006-01-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)