CLASS II Device recall · Reported 15 May 2013 · FDA Enforcement Report
Stryker Irrigator Reusable Tips: Regular Tip with 2 Hole recalled
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips: Regular Tip with 2 Hole, Metal 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-1227-2013
- 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
- Foreign Material
- 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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal 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 with 2 Hole, Metal Finish recalled?
Yes. Stryker Endoscopy recalled Stryker Irrigator Reusable Tips: Regular Tip with 2 Hole, Metal Finish on 27 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1227-2013.
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: 250-070-472
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.
More recalls from Stryker Endoscopy
All 238| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PneumoSure XL High Flow Insufflator recalled by Stryker Endoscopy | Stryker Endoscopy | Other | Nationwide |
| Device | CLASS II | Serfas 90 degree Energy Probe recalled by Stryker Endoscopy | Stryker Endoscopy | Device Malfunction | Nationwide |
| Device | CLASS II | Pkg, Pennington Forceps recalled by Stryker Endoscopy | Stryker Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Pkg Peek Handle recalled by Stryker Endoscopy | Stryker Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Pkg Insert, Johann Forceps recalled by Stryker Endoscopy | Stryker Endoscopy | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |