Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Lot Codes / Batch Numbers
GTIN: 20884521064710, 10884521064713 Model # Lot # D-1764K D1L2420Y D1L2428Y D1M2883Y
Products Sold
GTIN: 20884521064710, 10884521064713 Model # Lot # D-1764K D1L2420Y D1L2428Y D1M2883Y
A medical device manufacturer is recalling Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45 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