Z-0128-2022Class II

IUD Insertion Kit

Name: Z-0128-2022 IUD Insertion Kit
Creator: Stradis Medical, LLC dba Stradis Healthcare
Published: 2021-09-10
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2021-09-10 / Open, Classified / root cause: design

FDA source

Stradis Medical, LLC dba Stradis Healthcare began a recall of IUD Insertion Kit on 2021-09-10. FDA classified it as Class II and gives the reason as "Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0128-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-10
Posted: 2021-10-16
Recalling firm: Gyn-Disposables, Inc.
Product: IUD Insertion Kit
Product code: HDC Tenaculum, Uterine
Reason for recall: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Part Number: 935K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0127-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0128-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0129-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0130-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0131-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16

Product code HDC

K073182Class IIGyn Disposables Tenaculum 356TGyn-Disposables, Inc. / cleared 2007-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)