Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip Recalled by Stryker Endoscopy Due to The pre-vacuum steam sterilization (wrapped method) temperature in...

Date: March 27, 2013
Company: Stryker Endoscopy
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Endoscopy directly.

Affected Products

Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

Quantity: 147,921 - all sizes

Why Was This Recalled?

The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Endoscopy

Stryker Endoscopy has 238 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report