RecallRadar

FDA Device recall Z-0732-2016

PS-500 Scope Warmer

On 2016-02-10 the FDA classified a Class II recall of PS-500 Scope Warmer by Josnoe Medical, citing damage to package seals potentially compromising sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0732-2016
ClassificationClass II
Statusterminated
Initiated2015-12-01
Published2016-02-10
Last updated2026-09-13 11:54 UTC
CompanyJosnoe Medical
DistributionUS

Product

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

Reason

Damage to package seals potentially compromising sterility.

Identifiers

code_infoLot# G154341 Exp: 4/14/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0732-2016%22

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