Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-17 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-17
Lot Codes / Batch Numbers
GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739
Products Sold
GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739, 20884521086422. Model Number Lot # CS211 D1L1576Y D2B0747Y CS490 D2C2519Y CS562 D1G1928Y GS823 D1K1923Y D2D1396Y GS835 D1E1757Y S1172 D2C2304Y S1173 D2C2305Y D2E1385Y S1174 D1M1794FY D1M2954FY D1M2984FY S1750K D2E2348Y S176 D2B1886Y S176 D2C1977Y S1768K D1M1759Y D2B2217Y S182 D1L1613Y D2B0177Y S183 D1M1421Y D2E1280Y S184 D1L3136Y D1M2895Y D2D0954Y D2D0964Y D2D0967Y D2D0972Y S185 D2B2785Y D2B2877Y D2B2878Y D2C1421Y D2D0957Y D2D0968Y D2D0971Y D2D0984Y D2D0985Y D2E2680Y D2E2767Y D2E2769Y S187 D2A1585Y S206 D1L2658Y D1M2896Y D2A1586Y S243 D1M1020Y D2D2348Y S244 D1M1590Y S245 D2A0559Y D2C2036Y D2C2162Y D2D1871Y S246 D2E1375Y S2782K D2F0062Y S303 D1M1424Y D2C1472Y D2D1872Y D2D2120Y D2E1496Y S304 D2B0173Y D2C2163Y D2C2805Y D2D1991Y D2E1484Y S305 D1L3282Y D1L3459Y D2C1280Y D2C1281Y D2C1479Y D2D0959Y D2E0907Y D2E2768Y D2E2772Y S316 D1L3311Y D1M0530Y D2A0555Y D2A0557Y D2A0558Y D2A0866Y D2C2806Y D2D2434Y D2D2436Y S317 D2D2087Y D2E0587Y S318 D1M0153Y D2A1677Y S346 D2A0867Y D2B1884Y S605 D1L2686Y D2B2244Y S607 D1M2899Y S608 D1L1617Y D1L1619Y D1L1622Y D1M0173Y D1M0635Y D1M0655Y D2E1210Y SS523 D2C1971Y SS525 D1G1346Y SS5641 D2B2181FY SS5641G D1D2533FY SS5678 D1L2430FY SS5684 D2B1970FY SS623 D1G0960Y D2A1069Y SS645 D1K2457FY D1L3151FY D1M2526FY D1M2531FY SS653 D1E2737FY SS673 D1L0164FY SS683G D1L0794FY SS685G D2A0503FY SS686 D1E0201FY SS689 D2C0024FY SS745 D1M2971FY SS786 D1E1220FY SS787 D1L0032FY VS533 D1M0598Y VS845 D2B1779Y VS870 D1M2873Y VS871 D1L0602Y VS8712 D2C3153Y VS872 D1M1837Y D2C2945Y VS8722 D1D3187Y D1M1292Y VS882 D1G1139Y VS8902 D2B0364Y XX5278 D2B0174Y XX5280 D2E1482Y XX5281 D2B0175Y XX5284 D1L2691Y
A medical device manufacturer is recalling Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X due to Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Recommended Action
Per FDA guidance
Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to rs.gmbfcamitg@medtronic.com.> " Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below. " Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. Shipping and Return Instructions: " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit or Replacement for the returned affected product will be issued based on the RGA number. " Return all unused and non-expired affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
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