COMFORT SHIELD Barrier Cream Cloths (Sage) – Potential Contamination (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;
Brand
Sage Products LLC
Lot Codes / Batch Numbers
Lot #: a) 45489, Exp. 8/23/2016, 45537, Exp. 8/25/2016, 45631, Exp. 9/1/2016, 45781, Exp. 9/10/2016, 46345, Exp. 10/18/2016, 46708, Exp. 11/9/2016, 46763, Exp. 11/11/2016, 47378, Exp. 1/5/2017, 47723, Exp. 1/27/2017, 48347, Exp. 3/4/2017, 49057, Exp. 4/18/2017, 49498, Exp. 5/16/2017, 49576, Exp. 5/19/2017, 49869, Exp. 6/8/2017, 51306, Exp. 9/10/2017, 51309, Exp. 9/10/2017, 51720, Exp. 10/6/2017, 52187, Exp. 11/7/2017, 52216, Exp. 11/8/2017, 52226, Exp. 11/8/2017, 52235, Exp. 11/9/2017, 52239, Exp. 11/9/2017, 52415, Exp. 11/19/2017, 52694, Exp. 12/8/2017, 52702, Exp. 12/8/2017, 52711, Exp. 12/9/2017, 52722, Exp. 12/9/2017, 52968, Exp. 1/4/2018, 53000, Exp. 1/5/2018, 54543, Exp. 4/10/2018, 54597, Exp. 4/12/2018, 55814, Exp. 6/20/18, b) 45408, Exp. 8/17/2016, 45427, Exp. 8/18/2016, 45451, Exp. 8/19/2016, 45468, Exp. 8/20/2016, 45483, Exp. 8/21/2016, 45557, Exp. 8/26/2016, 45650, Exp. 9/2/2016, 45768, Exp. 9/9/2016, 45893, Exp. 9/17/2016, 45998, Exp. 9/23/2016, 46169, Exp. 10/5/2016, 46432, Exp. 10/22/2016, 46512, Exp. 10/27/16, 46551, Exp. 10/29/16, 46608, Exp. 11/2/16, 46647, Exp. 11/4/2016, 46669, Exp. 11/6/2016, 46841, Exp. 11/17/2016, 46851, Exp. 11/17/2016, 46970, Exp. 11/29/2016, 47058, Exp. 12/2/2016, 47115, Exp. 12/7/2016, 47202, Exp. 12/14/2016, 47309, Exp. 12/20/2016, 47420, Exp. 1/8/2017, 47436, Exp. 1/10/2017, 47512, Exp. 1/13/2017, 47560, Exp. 1/17/2017, 47800, Exp. 2/2/2017, 47837, Exp. 2/3/2017, 48134, Exp. 2/19/2017, 48154, Exp. 2/21/2017, 48928, Exp. 4/9/2017, 48943, Exp. 4/11/2017, 49149, Exp. 4/25/2017, 49222, Exp. 4/29/2017, 49386, Exp. 5/9/2017, 49466, Exp. 5/12/2017, 49600, Exp. 5/20/2017, 49926, Exp. 6/13/2017, 50578, Exp. 7/27/2017, 50585, Exp. 7/27/2017, 50596, Exp. 7/28/2017, 50600, Exp. 7/28/2017, 50910, Exp. 8/15/2017, 51204, Exp. 9/6/2017, 51260, Exp. 9/8/2017, 51268, Exp. 9/8/2017, 51293, Exp. 9/9/2017, 51344, Exp. 9/13/2017, 51438, Exp. 9/19/2017, 51522, Exp. 9/23/2017, 51527, Exp. 9/23/2017, 51531, Exp. 9/23/2017, 51755, Exp. 10/7/2017, 51824, Exp. 10/13/2017, 52016, Exp. 10/26/2017, 52079, Exp. 10/29/2017, 52083, Exp. 10/31/2017, 52263, Exp. 11/10/2017, 52308, Exp. 11/14/2017, 52397, Exp. 11/18/2017, 52407, Exp. 11/18/2017, 52538, Exp. 11/29/2017, 52614, Exp. 12/5/2017, 52615, Exp. 12/5/2017, 52644, Exp. 12/6/2017, 52659, Exp. 12/6/2017, 52661, Exp. 12/7/2017, 52676, Exp. 12/7/2017, 52737, Exp. 12/12/2017, 52946, Exp. 1/3/2018, 53359, Exp. 1/25/2018, 53624, Exp. 2/14/2018, 53724, Exp. 2/20/2018, 53849, Exp. 2/27/2018, 53850, Exp. 2/27/2018, 54498, Exp. 4/6/2018, 54544, Exp. 4/10/2018, 54653, Exp. 4/17/2018, 54693, Exp. 4/18/2018, 54734, Exp. 4/20/2018, 54771, Exp. 4/24/2018, 54856, Exp. 4/28/2018, 54945, Exp. 5/4/2018, 55365, Exp. 5/30/2018, 55629, Exp. 6/12/2018, 56255, Exp. 7/18/2018, 56263, Exp. 7/19/2018, 56273, Exp. 7/19/2018, 56353, Exp. 7/24/2018, 56410, Exp. 7/27/18, 56413, Exp. 7/27/18, 56532, Exp. 8/3/18, c) 46225, Exp. 10/8/2016, 46554, Exp. 10/29/2016, 46915, Exp. 11/22/2016, 49296, Exp. 5/3/2017, 49343, Exp. 5/5/2017, 50105, Exp. 6/23/17, 50626, Exp. 7/30/2017, 50634, Exp. 7/30/2017, 50639, Exp. 7/30/2017, 51310, Exp. 9/12/2017, 51313, Exp. 9/12/2017, 51340, Exp. 9/13/2017, 52388, Exp. 11/17/2017, 52395, Exp. 11/18/2017, 52403, Exp. 11/18/2017, 52421, Exp. 11/19/2017, 52912, Exp. 12/21/2017, 52915, Exp. 12/22/2017, 52918, Exp. 12/22/2017, 53508, Exp. 2/6/2018, 54815, Exp. 4/26/2018, 56307, Exp. 7/20/2018, 56311, Exp. 7/21/2018, 56316, Exp. 7/21/2018, 56457, Exp. 7/29/2018, 56561, Exp. 8/4/18, d) 53304, Exp. 1/23/2018, 53339, Exp. 1/24/2018, 53342, Exp. 1/24/2018, 53357, Exp. 1/25/2018, 55784, Exp. 6/19/2018, e) 50806, Exp. 2/7/2017, 52305, Exp. 5/15/2017, f) 48066, Exp. 8/18/2016, 48110, Exp. 8/20/2016, 48596, Exp. 9/20/2016, 48668, Exp. 9/23/2016, 49249, Exp. 11/1/2016, 49335, Exp. 11/4/2016, 49535, Exp. 11/16/2016, 50614, Exp. 1/28/2017, 50702, Exp. 2/2/2017, 50988, Exp. 2/21/2017, 51288, Exp. 3/11/2017, 51715, Exp. 4/6/2017, 51745, Exp. 4/8/2017, 51749, Exp. 4/8/2017, 51754, Exp. 4/8/2017, 51765, Exp. 4/9/2017, 51870, Exp. 4/18/2017, 52484, Exp. 5/26/2017, 52864, Exp. 6/20/2017, 53398, Exp. 8/1/2017, 54081, Exp. 9/12/2017, 54373, Exp. 9/29/2017, 55537, Exp. 12/7/2017, 56020, Exp. 1/4/2018, 56107, Exp. 1/9/2018
Products Sold
Lot #: a) 45489, Exp. 8/23/2016; 45537, Exp. 8/25/2016; 45631, Exp. 9/1/2016; 45781, Exp. 9/10/2016; 46345, Exp. 10/18/2016; 46708, Exp. 11/9/2016; 46763, Exp. 11/11/2016; 47378, Exp. 1/5/2017; 47723, Exp. 1/27/2017; 48347, Exp. 3/4/2017; 49057, Exp. 4/18/2017; 49498, Exp. 5/16/2017; 49576, Exp. 5/19/2017; 49869, Exp. 6/8/2017; 51306, Exp. 9/10/2017; 51309, Exp. 9/10/2017; 51720, Exp. 10/6/2017; 52187, Exp. 11/7/2017; 52216, Exp. 11/8/2017; 52226, Exp. 11/8/2017; 52235, Exp. 11/9/2017; 52239, Exp. 11/9/2017; 52415, Exp. 11/19/2017; 52694, Exp. 12/8/2017; 52702, Exp. 12/8/2017; 52711, Exp. 12/9/2017; 52722, Exp. 12/9/2017; 52968, Exp. 1/4/2018; 53000, Exp. 1/5/2018; 54543, Exp. 4/10/2018; 54597, Exp. 4/12/2018; 55814, Exp. 6/20/18; b) 45408, Exp. 8/17/2016; 45427, Exp. 8/18/2016; 45451, Exp. 8/19/2016; 45468, Exp. 8/20/2016; 45483, Exp. 8/21/2016; 45557, Exp. 8/26/2016; 45650, Exp. 9/2/2016; 45768, Exp. 9/9/2016; 45893, Exp. 9/17/2016; 45998, Exp. 9/23/2016; 46169, Exp. 10/5/2016; 46432, Exp. 10/22/2016; 46512, Exp. 10/27/16; 46551, Exp. 10/29/16; 46608, Exp. 11/2/16; 46647, Exp. 11/4/2016; 46669, Exp. 11/6/2016; 46841, Exp. 11/17/2016; 46851, Exp. 11/17/2016; 46970, Exp. 11/29/2016; 47058, Exp. 12/2/2016; 47115, Exp. 12/7/2016; 47202, Exp. 12/14/2016; 47309, Exp. 12/20/2016; 47420, Exp. 1/8/2017; 47436, Exp. 1/10/2017; 47512, Exp. 1/13/2017; 47560, Exp. 1/17/2017; 47800, Exp. 2/2/2017; 47837, Exp. 2/3/2017; 48134, Exp. 2/19/2017; 48154, Exp. 2/21/2017; 48928, Exp. 4/9/2017; 48943, Exp. 4/11/2017; 49149, Exp. 4/25/2017; 49222, Exp. 4/29/2017; 49386, Exp. 5/9/2017; 49466, Exp. 5/12/2017; 49600, Exp. 5/20/2017; 49926, Exp. 6/13/2017; 50578, Exp. 7/27/2017; 50585, Exp. 7/27/2017; 50596, Exp. 7/28/2017; 50600, Exp. 7/28/2017; 50910, Exp. 8/15/2017; 51204, Exp. 9/6/2017; 51260, Exp. 9/8/2017; 51268, Exp. 9/8/2017; 51293, Exp. 9/9/2017; 51344, Exp. 9/13/2017; 51438, Exp. 9/19/2017; 51522, Exp. 9/23/2017; 51527, Exp. 9/23/2017; 51531, Exp. 9/23/2017; 51755, Exp. 10/7/2017; 51824, Exp. 10/13/2017; 52016, Exp. 10/26/2017; 52079, Exp. 10/29/2017; 52083, Exp. 10/31/2017; 52263, Exp. 11/10/2017; 52308, Exp. 11/14/2017; 52397, Exp. 11/18/2017; 52407, Exp. 11/18/2017; 52538, Exp. 11/29/2017; 52614, Exp. 12/5/2017; 52615, Exp. 12/5/2017; 52644, Exp. 12/6/2017; 52659, Exp. 12/6/2017; 52661, Exp. 12/7/2017; 52676, Exp. 12/7/2017; 52737, Exp. 12/12/2017; 52946, Exp. 1/3/2018; 53359, Exp. 1/25/2018; 53624, Exp. 2/14/2018; 53724, Exp. 2/20/2018; 53849, Exp. 2/27/2018; 53850, Exp. 2/27/2018; 54498, Exp. 4/6/2018; 54544, Exp. 4/10/2018; 54653, Exp. 4/17/2018; 54693, Exp. 4/18/2018; 54734, Exp. 4/20/2018; 54771, Exp. 4/24/2018; 54856, Exp. 4/28/2018; 54945, Exp. 5/4/2018; 55365, Exp. 5/30/2018; 55629, Exp. 6/12/2018; 56255, Exp. 7/18/2018; 56263, Exp. 7/19/2018; 56273, Exp. 7/19/2018; 56353, Exp. 7/24/2018; 56410, Exp. 7/27/18; 56413, Exp. 7/27/18; 56532, Exp. 8/3/18; c) 46225, Exp. 10/8/2016; 46554, Exp. 10/29/2016; 46915, Exp. 11/22/2016; 49296, Exp. 5/3/2017; 49343, Exp. 5/5/2017; 50105, Exp. 6/23/17; 50626, Exp. 7/30/2017; 50634, Exp. 7/30/2017; 50639, Exp. 7/30/2017; 51310, Exp. 9/12/2017; 51313, Exp. 9/12/2017; 51340, Exp. 9/13/2017; 52388, Exp. 11/17/2017; 52395, Exp. 11/18/2017; 52403, Exp. 11/18/2017; 52421, Exp. 11/19/2017; 52912, Exp. 12/21/2017; 52915, Exp. 12/22/2017; 52918, Exp. 12/22/2017; 53508, Exp. 2/6/2018; 54815, Exp. 4/26/2018; 56307, Exp. 7/20/2018; 56311, Exp. 7/21/2018; 56316, Exp. 7/21/2018; 56457, Exp. 7/29/2018; 56561, Exp. 8/4/18; d) 53304, Exp. 1/23/2018; 53339, Exp. 1/24/2018; 53342, Exp. 1/24/2018; 53357, Exp. 1/25/2018; 55784, Exp. 6/19/2018; e) 50806, Exp. 2/7/2017; 52305, Exp. 5/15/2017; f) 48066, Exp. 8/18/2016; 48110, Exp. 8/20/2016; 48596, Exp. 9/20/2016; 48668, Exp. 9/23/2016; 49249, Exp. 11/1/2016; 49335, Exp. 11/4/2016; 49535, Exp. 11/16/2016; 50614, Exp. 1/28/2017; 50702, Exp. 2/2/2017; 50988, Exp. 2/21/2017; 51288, Exp. 3/11/2017; 51715, Exp. 4/6/2017; 51745, Exp. 4/8/2017; 51749, Exp. 4/8/2017; 51754, Exp. 4/8/2017; 51765, Exp. 4/9/2017; 51870, Exp. 4/18/2017; 52484, Exp. 5/26/2017; 52864, Exp. 6/20/2017; 53398, Exp. 8/1/2017; 54081, Exp. 9/12/2017; 54373, Exp. 9/29/2017; 55537, Exp. 12/7/2017; 56020, Exp. 1/4/2018; 56107, Exp. 1/9/2018
Sage Products LLC is recalling COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in fle due to CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
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 noticePage updated: Jan 7, 2026