The Recall Desk
ModerateFDA (Devices)·Z-0732-2016·Announced 2016-02-10

JosNoe PS-500 Scope Warmer Recalled for Package Seal Damage

JosNoe Medical is recalling PS-500 Scope Warmers because damaged package seals may compromise sterility. The recall covers 1,008 boxes distributed in the US and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential sterility compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

JosNoe Medical, Inc. is recalling 1,008 boxes of PS-500 Scope Warmers. These devices are used to pre-heat scopes for laparoscopy surgery. The recall is due to damage to package seals, which potentially compromises the sterility of the devices.

The affected units are identified by Lot # G154341 with an expiration date of 4/14/18. The products were distributed nationwide in the United States and in Canada.

Consumers and healthcare facilities should stop using the recalled devices and contact JosNoe Medical for further instructions.

The recalled product

Product
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Manufacturer
JosNoe Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,008

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# G154341 Exp: 4/14/18

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · sterility compromise

See all →