Z-1163-2010

Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a...

Name: Z-1163-2010 Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a...
Creator: Olympus America Inc.
Published: 2010-02-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2010-02-08 / Terminated / root cause: manufacturing process

FDA source

Olympus America Inc. began a recall of Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for... on 2010-02-08. The reason FDA records is "weak weld seams". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1163-2010
Status: Terminated
Initiated: 2010-02-08
Posted: 2010-03-18
Terminated: 2010-05-25
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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.
Product code: KOG
Reason for recall: weak weld seams
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 45
Distribution: Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
Product codes and lots: Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW

Product code KOG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)