CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report
Stryker Irrigator Reusable Tips: Regular Tip, vented recalled
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips: Regular Tip, vented, Non-Reflective Finish, distributed nationwide in the US. The recall was initiated on 27 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1230-2013
- FDA event ID
- 64682
- Recalling firm
- Stryker Endoscopy, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Mar 2013
- FDA classified
- 3 May 2013
- Reported
- 15 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 27 Mar 2013 | Recall initiated by company | |
| 3 May 2013 | Classified by FDA | +37 days |
| 15 May 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Where it was distributed
Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
Questions about this recall
Is Stryker Irrigator Reusable Tips: Regular Tip, vented, Non-Reflective Finish recalled?
Yes. Stryker Endoscopy recalled Stryker Irrigator Reusable Tips: Regular Tip, vented, Non-Reflective Finish on 27 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1230-2013.
Why was it 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.
Which lots are affected?
Manufacturer Part Number: 250-070-483
Where was it sold?
Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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