CLASS II ONGOING Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

TDX SP2 recalled by Invacare

Invacare is recalling Invacare TDX SP2, distributed nationwide in the US. The recall was initiated on 30 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI (DI): Model Number Device Identifier TDXSP2 00841447100911 TDXSP2-MCG 00841447100966 TDXSP2V 00841447101512 Serial Numbers: 22CE000031 22BE004288 22BE002669 22BE003672 22BE004782 22BE004151 22CE000984 22BE004286 22BE004171 22BE004540 22CE001086 22BE003661 22CE000184 22CE000878 22CE001449 22CE000032 22CE001421 22BE004933 22CE001002 22CE000180 22CE000725 22BE004544 22BE005009 22BE003671 22BE004284 22BE004159 22BE004285 22BE002652 22BE004282 22BE004798 22BE004281 22BE004170 22CE000182 22CE000183 22CE000876 22CE000873 22CE000981 22CE000870 22CE000871 22CE001248 22CE001004 22CE001084 22BE004776 22BE004165 22BE004931 22BE005010 22CE000875 22CE000728 22CE000727 22BE004910 22BE004904 22BE005007 22BE004160 22BE004169 22BE004175 22BE004166 22BE004905 22CE001420 22CE000496 22BE003645 22BE002651 22CE000999 22CE001078 22BE004545 22BE004763 22BE003662 22BE004929 22BE004937 22BE004176 22BE004903 22CE000181 22BE004167 22BE005006 22BE002666 22BE004177 22BE003962 22BE003957 22BE004173 22BE003664 22BE003659 22BE004767 22BE004940 22BE004777 22BE004538 22CE000186 22CE000867 22BE002935 22BE003959 22CE000493 22CE001077 22BE002934 22CE000726 22BE005004 22CE001251 22BE003961 22BE003673 22BE004902 22BE002936 22BE004801 22BE004287 22BE004995 22BE004539 22CE001075 22CE000490 22CE000879 22BE004168 22CE000847 22CE000033 22CE001005 22CE001006 22BE004765 22BE004768 22BE004769 22BE004770 22BE004911 22BE002932 22BE003960 22CE000874 22CE001253 22BE004930 22CE000178 22CE000179 22CE001080 22BE004174 22BE003963 22BE004935 22BE004775 22BE004172 22CE000177 22BE004543 22BE004764 22BE004766 22CE001076

Quantity recalled133 devices

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-1130-2022
FDA event ID: 90084
Recalling firm: Invacare, Elyria, OH
Classification: Class II
Status: Ongoing
Recall initiated: 30 Mar 2022
FDA classified: 25 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Mar 2022	Recall initiated by company
25 May 2022	Classified by FDA	+56 days
1 Jun 2022	Published in enforcement report	+7 days

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

Reason for recall

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada.

Nationwide Alaska Arkansas California Connecticut Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi

Questions about this recall

Is TDX SP2 recalled?

Yes. Invacare recalled TDX SP2 on 30 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1130-2022.

Why was it recalled?

Which lots are affected?

UDI (DI): Model Number Device Identifier TDXSP2 00841447100911 TDXSP2-MCG 00841447100966 TDXSP2V 00841447101512 Serial Numbers: 22CE000031 22BE004288 22BE002669 22BE003672 22BE004782 22BE004151 22CE000984 22BE004286 22BE004171 22BE004540 22CE001086 22BE003661 22CE000184 22CE000878 22CE001449 22CE000032 22CE001421 22BE004933 22CE001002 22CE000180 22CE000725 22BE004544 22BE005009 22BE003671 22BE004284 22BE004159 22BE004285 22BE002652 22BE004282 22BE004798 22BE004281 22BE004170 22CE000182 22CE000183 22CE000876 22CE000873 22CE000981 22CE000870 22CE000871 22CE001248 22CE001004 22CE001084 22BE004776 22BE004165 22BE004931 22BE005010 22CE000875 22CE000728 22CE000727 22BE004910 22BE004904 22BE005007 22BE004160 22BE004169 22BE004175 22BE004166 22BE004905 22CE001420 22CE000496 22BE003645 22BE002651 22CE000999 22CE001078 22BE004545 22BE004763 22BE003662 22BE004929 22BE004937 22BE004176 22BE004903 22CE000181 22BE004167 22BE005006 22BE002666 22BE004177 22BE003962 22BE003957 22BE004173 22BE003664 22BE003659 22BE004767 22BE004940 22BE004777 22BE004538 22CE000186 22CE000867 22BE002935 22BE003959 22CE000493 22CE001077 22BE002934 22CE000726 22BE005004 22CE001251 22BE003961 22BE003673 22BE004902 22BE002936 22BE004801 22BE004287 22BE004995 22BE004539 22CE001075 22CE000490 22CE000879 22BE004168 22CE000847 22CE000033 22CE001005 22CE001006 22BE004765 22BE004768 22BE004769 22BE004770 22BE004911 22BE002932 22BE003960 22CE000874 22CE001253 22BE004930 22CE000178 22CE000179 22CE001080 22BE004174 22BE003963 22BE004935 22BE004775 22BE004172 22CE000177 22BE004543 22BE004764 22BE004766 22CE001076

Where was it sold?

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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30 Aug 2023Device	CLASS II	Dolomite Gloss Rollator - intended to support during recalled	Invacare	Foreign Material	Nationwide
20 Jul 2022Device	CLASS III	Platinum 5NXG Oxygen Concentrator recalled by Invacare	Invacare	Other	18 states
12 Jan 2022Device	CLASS II	Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare	Invacare	Other	Nationwide
12 Jan 2022Device	CLASS II	TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled	Invacare	Other	Nationwide
12 Jan 2022Device	CLASS II	Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled	Invacare	Other	Nationwide

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