Z-0732-2016Class II

PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery

Name: Z-0732-2016 PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery
Creator: JosNoe Medical, Inc.
Published: 2015-12-01
License: https://open.fda.gov/license/

JosNoe Medical Inc / initiated 2015-12-01 / Terminated / root cause: packaging

FDA source

JosNoe Medical, Inc. began a recall of PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery on 2015-12-01. FDA classified it as Class II and gives the reason as "Damage to package seals potentially compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0732-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2016-01-30
Terminated: 2016-03-22
Recalling firm: JosNoe Medical Inc
Product: PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Product code: NWV Laparoscopic Accessories, Gynecologic
Reason for recall: Damage to package seals potentially compromising sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product.
Quantity in commerce: 1008 boxes
Distribution: Distributed US (nationwide) and in Canada.
Product codes and lots: Lot# G154341 Exp: 4/14/18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0732-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0732-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-01-30

Product code NWV

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)