Z-1642-2015Class II

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only

Name: Z-1642-2015 DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only
Creator: DeRoyal Industries Inc
Published: 2015-04-17
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2015-04-17 / Terminated / root cause: design

FDA source

DeRoyal Industries Inc began a recall of DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in... on 2015-04-17. FDA classified it as Class II and gives the reason as "The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1642-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-17
Posted: 2015-05-21
Terminated: 2015-12-29
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Root cause tag: design
FDA root cause: Device Design
Action: DeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of Destruction Form so that we may issue credit appropriately. 5. Return both forms to [email protected] or 865-362-3716 (fax) even if you no longer have affected inventory. 6. Once we have received your Recall Response and Notice of Destruction forms, you will receive credit for destroyed product as indicated on the form. 7. If you are a distributor of these products, please forward this recall notice on to your end-users, or provide us with your customer listing and we will gladly contact them for you. For questions regarding this recall, please contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.
Quantity in commerce: 5359 units
Distribution: US Nationwide Distribution
Product codes and lots: 1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1642-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1642-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-21

Product code GCJ

K132375Class IIGenistrong Single-Use Specimen Retrieval BagGenicon / cleared 2014-06-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)