Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949… recallZ-1163-2010 · Olympus America Inc. · initiated Feb 8, 2010
Terminated All recalls posted in March 2010
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 Olympus America Inc. 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
weak weld seams
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product.
Recall details
- Recall number
- Z-1163-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 8, 2010
- Posted by the FDA
- Mar 18, 2010
- Recalling firm
- Olympus America Inc.
- Quantity
- 45
- Product code
- KOG
- FDA submissions
- K790071, K923982
- Distribution
- Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
Product description
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall.
Code information (models, lots, serial numbers)
Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW
Other devices under the same FDA submission
3 devices cleared under K790071, K923982 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Olympus WA51138AOLYMPUS Winter & Ibe GmbH · Laparoscope, General & Plastic Surgery11 reports
- Olympus WA58365SOLYMPUS Winter & Ibe GmbH · Laparoscope, General & Plastic Surgery7 reports
- Olmypus WA63728AOLYMPUS Winter & Ibe GmbH · Mediastinoscope, Surgical1 report
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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