CLASS II Device recall · Reported 11 Feb 2015 · FDA Enforcement Report

G- Series Beds recalled by Invacare

Invacare is recalling G- Series Beds, distributed nationwide in the US. The recall was initiated on 5 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel G5510 Date codes: 40121 40122 40130 40131 40201 40204 40205 40206 40210 40211 40212 40213 40214 40217 40218 40219 40220 40221 40224 40225 40226 40227 40228 40303 40304 40305 40306 40307 40310 40311 40312 40313 40314 40319 40325 40326 40327 40331 40401 40402 40403 40404 40410 40411 40414 40415 40416 40421 40422 40423 40424 40425 40429 40429 40430 40501 40502 40506 40507 40508 40512 40513 40514 40515 40516 40519 40520 40521 40522 40523 40526 40527 40528 40529 40530 40603 40604 40605 40606 40610 40611 40612 40613 40616 40617 40618 40619 40620 40623 40624 40625 40626 40627 40630 40701 40702 40703 40707 40708 40709 40714 40715 40716 40717 40721 40722 40723 40724 40728 40729 40730 40731 40805 40806 40807 40811 40812 40813 40818 40819 40820 40825 40826 40901 40902 40904

Quantity recalled2499 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1036-2015
FDA event ID: 69450
Recalling firm: Invacare, Elyria, OH
Classification: Class II
Status: Terminated
Recall initiated: 5 Dec 2014
FDA classified: 2 Feb 2015
Reported: 11 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

5 Dec 2014	Recall initiated by company
2 Feb 2015	Classified by FDA	+59 days
11 Feb 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

G- Series Beds; G29 full length bed rails assembly

Where it was distributed

US Nationwide Distribution including OH, CO, MO, and NY.

Nationwide Colorado Missouri New York

Questions about this recall

Is G- Series Beds recalled?

Yes. Invacare recalled G- Series Beds on 5 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1036-2015.

Why was it recalled?

Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.

Which lots are affected?

Model G5510 Date codes: 40121 40122 40130 40131 40201 40204 40205 40206 40210 40211 40212 40213 40214 40217 40218 40219 40220 40221 40224 40225 40226 40227 40228 40303 40304 40305 40306 40307 40310 40311 40312 40313 40314 40319 40325 40326 40327 40331 40401 40402 40403 40404 40410 40411 40414 40415 40416 40421 40422 40423 40424 40425 40429 40429 40430 40501 40502 40506 40507 40508 40512 40513 40514 40515 40516 40519 40520 40521 40522 40523 40526 40527 40528 40529 40530 40603 40604 40605 40606 40610 40611 40612 40613 40616 40617 40618 40619 40620 40623 40624 40625 40626 40627 40630 40701 40702 40703 40707 40708 40709 40714 40715 40716 40717 40721 40722 40723 40724 40728 40729 40730 40731 40805 40806 40807 40811 40812 40813 40818 40819 40820 40825 40826 40901 40902 40904

Where was it sold?

US Nationwide Distribution including OH, CO, MO, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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