FDA Medical Device Recalls (openFDA)
Stradis Medical, LLC dba Stradis Healthcare: IUD Insertion Kit
- Recall number
- Z-0128-2022
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- IUD Insertion Kit
- Status
- Open, Classified
- Initiated
- 2021-09-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Root cause
- Device Design
- Action
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that the consignee has taken all necessary actions as described above.
- Quantity
- 14959 kits
- Distribution
- Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
- Lot, serial or model codes
- Part Number: 935K
- 510(k) numbers
- ["K073182"]
- PMA numbers
- not on file
- Product code
- HDC
- Firm FEI
- 1000111025
- Firm city
- Peachtree Corners
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28