StrykeFlow II Disposable Suction/Irrigator recallZ-0279-06 · Stryker Endoscopy · initiated Nov 18, 2005
Terminated All recalls posted in December 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices for which sterility may be compromised as evidenced by a crack in the package.
FDA root cause category: Other
What the company is doing
On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Recall details
- Recall number
- Z-0279-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 18, 2005
- Posted by the FDA
- Dec 14, 2005
- Recalling firm
- Stryker Endoscopy
- Quantity
- 48405 boxes, 6 units per box
- Product code
- GCX
- FDA submissions
- K042454
- Distribution
- The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
Product description
StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
Code information (models, lots, serial numbers)
Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
Other devices under the same FDA submission
2 devices cleared under K042454 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AHTO 0250070640Stryker Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall2 reports
- AHTO 0250070601Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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