Z-3025-2011

GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S...

Name: Z-3025-2011 GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S...
Creator: GYN Disposables Inc
Published: 2011-07-29
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2011-07-29 / Terminated / root cause: manufacturing process

FDA source

GYN Disposables Inc began a recall of GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper... on 2011-07-29. The reason FDA records is "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3025-2011
Status: Terminated
Initiated: 2011-07-29
Posted: 2011-08-15
Terminated: 2012-10-29
Recalling firm: Gyn-Disposables, Inc.
Product: GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.
Product code: HDC Tenaculum, Uterine
Reason for recall: Lack of sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: GYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101.
Quantity in commerce: 3987 units
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number: 935K. Lot number: 61034034.

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)