FDA Medical Device Recalls (openFDA)
JosNoe Medical, Inc.: PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
- Recall number
- Z-0732-2016
- Recalling firm
- JosNoe Medical, Inc.
- Product
- PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
- Status
- Terminated
- Initiated
- 2015-12-01
- Posted
- 2016-01-30
- Terminated
- 2016-03-22
- Reason
- Damage to package seals potentially compromising sterility.
- 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
- 1008 boxes
- Distribution
- Distributed US (nationwide) and in Canada.
- Lot, serial or model codes
- Lot# G154341 Exp: 4/14/18
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NWV
- Firm FEI
- 3000718286
- Firm city
- Chelsea
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28