Z-1553-2022Class II

NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700

Name: Z-1553-2022 NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Creator: Stradis Medical, LLC dba Stradis Healthcare
Published: 2022-07-25
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-07-25 / Open, Classified / root cause: packaging

FDA source

Stradis Medical, LLC dba Stradis Healthcare began a recall of NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 on 2022-07-25. FDA classified it as Class II and gives the reason as "The sterile barrier may be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1553-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-25
Posted: 2022-08-18
Recalling firm: Gyn-Disposables, Inc.
Product: NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Product code: HTD Forceps
Reason for recall: The sterile barrier may be compromised.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Stradis notified its sole consignee on 07/25/2022 by email. The notice explained the reason for the recall and the hazard, and requested the consignee contact customer service to arrange for the return and credit of the affected product. Should the product be further distributed, the consignee was directed to notify its customers within 48 hours of receipt of the notice. Those customers were directed to contact Stradis directly to arrange return and credit.
Quantity in commerce: 825 units
Distribution: US Nationwide distribution in the state of SC.
Product codes and lots: SKU/Part Number: ZZ-0700; Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1553-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1552-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1553-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1554-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18

Product code HTD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)