Oto Med Grace Medical S-3500 Bone Dust Collector Recall: Sterile Pouch Holes Risk
Oto Med recalls S-3500 bone dust collectors with holes in sterile pouches that could cause infection during surgery. Affected units have specific lot numbers and were sold in 2006-2007. Stop using immediately to prevent infection risks.
Use caution until it’s fixed
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Contact the company
What happened, in plain English
Oto Med is recalling bone dust collectors used in ear surgery that have holes in their sterile packaging. This could allow bacteria to enter the surgical site, increasing infection risk during procedures. Read more at govinfonow.com/recall/63719-oto-med-grace-medical-s-3500-bone-dust-collector-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/63719-oto-med-grace-medical-s-3500-bone-dust-collector-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1520-2021
Cite this page
“Oto Med Grace Medical S-3500 Bone Dust Collector Recall: Sterile Pouch Holes Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63719-oto-med-grace-medical-s-3500-bone-dust-collector-recall. Based on FDA recall #Z-1520-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2021%22&limit=1).
Why it’s dangerous
The sterile Tyvek pouches that hold the bone dust collectors developed holes during testing. If these holes are present, bacteria could enter the surgical site during procedures, increasing infection risk.
Who’s affected
Surgical staff and hospitals that purchased the S-3500 bone dust collectors with specific lot numbers between 2006 and 2007. Those using the devices for ear surgery are most at risk.
How to tell if you have this one
Check for the model S-3500 with lot numbers listed: 019120G(2), 029119G(2), 039118G(2), 049119G(2), 0712119G(2), 0812118G(2), 0912118G(2), 1012119G(2), 1212118G(2), or 200602. These units were sold between 2006 and 2007.
- Brand
Oto Med- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1519-2021 | Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.; UDI Code: 00850000126046 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401 | 13,335 devices |
| Z-1520-2021 | Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.; UDI Code: 008500001260060 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200602 | 5,092 devices |
| Z-1521-2021 | Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.; UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2) | 415 devices |
What to do — step by step
Stop Using Immediately
Discontinue use of the S-3500 bone dust collectors with the listed lot numbers to prevent potential infection during surgery.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1520-2021 (December 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1520-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.