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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- 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.
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