Olympus Corporation of the Americas Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Lot number: PR898678
Products Sold
Lot number: PR898678
Olympus Corporation of the Americas is recalling Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 701421 due to Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
Recommended Action
Per FDA guidance
Olympus issued Urgent Medical Device Removal Action letter, dated July 14, 2020 via Federal Express stating reason for recall, health risk and action to take: 1.Immediately assess any affected product you have in stock and quarantine any affected product. 2.Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-XXXX and provide your contact information as indicated in the portal. 3. Olympus will issue a credit or replacement for your affected inventory. In addition, if you may have further distributed this product, please identify your customers, notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, GA, PA
Page updated: Jan 10, 2026