Z-1493-2014Class II

Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The...

Name: Z-1493-2014 Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2014-03-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-03-26 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body... on 2014-03-26. FDA classified it as Class II and gives the reason as "During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign...". 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-1493-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-26
Posted: 2014-04-24
Terminated: 2014-12-11
Recalling firm: Stryker Corp.
Product: Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
Product code: FYD Apparatus, Exhaust, Surgical
Reason for recall: During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On March 26, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL NOTIFICATION to their consignees via mail and email. Notification included product description, reason for recall, risk to health, and actions to be taken by the Customer/User. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Angela Ragainis/Kelly Jo Whipple 269-389-4354 / 269-389-2921 [email protected] / [email protected] Customers will be asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers will return affected product to Stericycle for destruction using a return label provided by Stryker or Stericycle. Upon receipt of affected product a credit will be issued to customer account. In addition, facilities are being asked to research their records for patient issues that may have been associated with the use of a recalled device, such as infection and/or inflammation.
Quantity in commerce: 35,310 unexpired units
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
Product codes and lots: Part Number 0702-045-027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1493-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1493-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code FYD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)