Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip — Class II medical device recall Z-1236-2013
Terminated recall by Stryker Endoscopy, reported 2013-05-15, distributed nationwide. The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed
| Recall number | Z-1236-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2013-03-27 |
| Classified | 2013-05-03 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2013-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CN, FR, GR, IN, JP, KR, MX, NL, NZ, PT, RO, SG, TW, ZA |
| Quantity | 147,921 |
| Model numbers | 250-070-490 |
Product
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1236-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.