Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.
Brand
Sunrise Medical
Lot Codes / Batch Numbers
Model 515ADS - serial number range A561137DS - A562049DS, Model 515ADZ - serial number range A538908DZ - A538924DZ, Model 515AKS - serial number range A542879KS - A543722KS, and Model 515AKZ - serial number A501627KZ.
Products Sold
Model 515ADS - serial number range A561137DS - A562049DS; Model 515ADZ - serial number range A538908DZ - A538924DZ; Model 515AKS - serial number range A542879KS - A543722KS; and Model 515AKZ - serial number A501627KZ.
Sunrise Medical is recalling DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. due to potential for sieve beds to have been incorrectly assembled. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
potential for sieve beds to have been incorrectly assembled
Recommended Action
Per FDA guidance
On 10/30/08, the recalling firm began to telephone customers of the problem. The recalling firm followed up with Urgent: Medical Device Recall letters, dated 11/7/2008. The letters requested that users cease the use of the affected device and immediately contact their provider to make arrangements to have the Concentrator replaced. The firm has set up a toll free line to assist customers with identification of affected units and the return process.
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
AL, CA, FL, GA, IL, IN, MD, MA, MI, MS, NE, NH, NM, NY, NC, PA, SD, TN, TX, VA, WI
Page updated: Jan 10, 2026