Sp78100, Sp78105 recallZ-0347-2011 · Micromedics, Inc. · initiated Mar 15, 2010
Terminated All recalls posted in November 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 Micromedics, 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
Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
FDA root cause category: Packaging process control
What the company is doing
Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.
Recall details
- Recall number
- Z-0347-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 15, 2010
- Posted by the FDA
- Nov 18, 2010
- Recalling firm
- Micromedics, Inc.
- Quantity
- 22
- Product code
- LFB
- FDA submissions
- K982667
- Distribution
- Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
Product description
SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. Nasal Products, Catalog Number SP-78105, Nasal Septal Button Oversize (5cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385.
Code information (models, lots, serial numbers)
Model / Lot #: SP78100 / 114149, SP78105 / 114219.
Other devices under the same FDA submission
1 device cleared under K982667 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SUMMIT MEDICAL SP-78105Summit Medical, Inc. · Button, Nasal Septal1 recall0 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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