FDA Device recall Z-2969-2018

Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device i…

FDA Device
Class II
terminated
Published 2018-09-12

On 2018-09-12 the FDA classified a Class II recall of Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device i… by Inspire Medical Systems, citing incorrect use-by date on the device registration/patient file labels.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2969-2018
Classification	Class II
Status	terminated
Initiated	2018-06-12
Published	2018-09-12
Last updated	2026-09-13 11:54 UTC
Company	Inspire Medical Systems
Distribution	US

Product

Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

Reason

Incorrect use-by date on the device registration/patient file labels.

Identifiers

code_info	UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box w… UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected serial numbers in the customer's stock: NCR202227H, NCR202230H, NCR202238H, NCR202244H, NCR202245H, NCR202246H, NCR202247H, NCR202252H, NCR202253H, NCR202254H, NCR202255H, NCR202259H, NCR202260H, NCR202261H, NCR202264H, NCR202266H, NCR202267H, NCR202268H, NCR202269H, NCR202270H, NCR202272H, NCR202273H, NCR202274H, NCR202275H, NCR202276H, NCR202277H, NCR202278H, NCR202279H, NCR202281H, NCR202282H, NCR202283H, NCR202284H, NCR202285H, NCR202287H, NCR202294H, NCR202306H, NCR202307H, NCR202314H, NCR202315H, NCR202317H, NCR202320H, NCR202324H, NCR202325H, NCR202328H, NCR202336H, NCR202337H, NCR202338H, NCR20

code_info

UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box w…

UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected serial numbers in the customer's stock: NCR202227H, NCR202230H, NCR202238H, NCR202244H, NCR202245H, NCR202246H, NCR202247H, NCR202252H, NCR202253H, NCR202254H, NCR202255H, NCR202259H, NCR202260H, NCR202261H, NCR202264H, NCR202266H, NCR202267H, NCR202268H, NCR202269H, NCR202270H, NCR202272H, NCR202273H, NCR202274H, NCR202275H, NCR202276H, NCR202277H, NCR202278H, NCR202279H, NCR202281H, NCR202282H, NCR202283H, NCR202284H, NCR202285H, NCR202287H, NCR202294H, NCR202306H, NCR202307H, NCR202314H, NCR202315H, NCR202317H, NCR202320H, NCR202324H, NCR202325H, NCR202328H, NCR202336H, NCR202337H, NCR202338H, NCR20

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-2969-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.