FDA Device recall Z-1493-2014
Stryker PenAdapt"
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of Stryker PenAdapt" by Stryker Instruments Div, citing during packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscop….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1493-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-26 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | Part Number 0702-045-027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2014%22
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