Natus Medical Incorporated recall records

3 reported ongoing

3 records in this archive. Latest source date Nov 28, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Class IIReported ongoing

Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR,...

Official source for External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
FDA device enforcement

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Class IIReported ongoing

Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR,...

Official source for EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
FDA device enforcement

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically...

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.

Official source for The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory an...

Reasons in these listed records

  • Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
  • Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

These examples come from this result page and are not a ranking of every recall reason.

Checking Natus Medical Incorporated

Is there a recall on natus medical incorporated right now?

This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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