Stradis Healthcare Surgical Suture Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Surgical Suture Kit
Brand
Stradis Healthcare
Lot Codes / Batch Numbers
Part Number: ZZ-0958, Primary DI Number: M752ZZ09580, Lot Numbers: 213639474, 212957814, 212675717
Products Sold
Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Stradis Healthcare is recalling Surgical Suture Kit due to There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Recommended Action
Per FDA guidance
The firm, Stradis Health, initiated an "URGENT: MEDICAL DEVICE RECALL" on 04/22/2022 via email. The letter instructs the consignee to examine your inventory and immediately quarantine any affected product; contact Stradis Customer Service to arrange or return, shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Service can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. Notify their customer within 48 hours and the customers should contact the firm to arrange for a return. The firm is also requesting that the consignees return an acknowledgement form. If you have any questions regarding this notification, please do not hesitate to contact us at 1-800-886-7257.
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
NC
Page updated: Jan 10, 2026