Cytrellis Biosystems, Inc. ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
Brand
Cytrellis Biosystems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI = B933ELCON010 S/N: SN 0101 0102 0103 0104 0105 0106 0107 0109 0111 0112 0113 0114 0115 0116 0117 0118 0119 0120 0121 0124 0126 0127 0128 0129 0130 0131 0132 0133 0134 0135 0136 0137 0138 0139 0140 0141 0142 0145 0146 0147 0148 0149 0151 0152 0153 0154 0155 0156 0157 0158 0160 0161 0162 0163 0165 0166 0167 0168 0169 0170 0172 0173 0174 0175 0177 0178 0179 0180 0181 0183 0184 0185 0186 0187 0188 0189 0190 0191 0192 0195 0196 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0211 0212 0213 0214 0215 0216 0218 0219 0220 0221 0222 0223 0224 0225 0226 0227 0228 0229 0231 0235 0236 0239 0240 0241 0242 0243 0244 0246 0247 0248 0249 0252 0254
Cytrellis Biosystems, Inc. is recalling ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treat due to Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring
Recommended Action
Per FDA guidance
Cytrellis Biosystems, Inc issued Urgent Medical Device Recall letter via email on 6/23/23 and revised letter on 7/7/23. Letter states reason for recall, health risk and action to take: A member of our service engineering team will be reaching out to your practice to schedule a visit to conduct the software update to your console on site. The visit will take approximately 30-45 minutes. Our goal for the completion of updates for all existing customers is by August 31st. Actions to be taken by the Customer: 1) If you drop or have dropped your handpiece, stop immediate use of the handpiece and contact Cytrellis. 2) Complete the attached Recall Return Response Form and provide it to the service engineering representative that conducts the software update on the device located at your site as acknowledgment of this recall. Any questions can be directed to medicalinformation@cytrellis.com. Website: www.cytrellis.com
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 10, 2026